MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-04-13 for SARA STEDY NTB2000 manufactured by Arjohuntleigh Magog Inc..
[72655081]
(b)(4). Additional information will be provided upon conclusion of the manufacturer's investigation.
Patient Sequence No: 1, Text Type: N, H10
[72655082]
(b)(4) has been informed about the incident involving sara stedy. From the information provided it was establised that the patient fell from the device. As a result of the incident the following injuries were sustained by patient (all to the right side of the body): laceration of arm, neck of femur, wrist, pain in leg and arm.
Patient Sequence No: 1, Text Type: D, B5
[74716828]
An investigation was carried out into this complaint. Arjohuntleigh received information about incident that occurred in (b)(6) hospital in (b)(6). It was reported that the resident was transferred from bed to sara stedy with assistance of two caregivers. While one of the caregivers was moving the patient on sara stedy towards the wardrobe and turning to open the door, the resident fell to the right side to the floor. Both caregivers immediately came to the resident and called for help. The resident already had a subdural hematoma and suffered with weakness on her right side. As an outcome of the incident, the patient sustained laceration of arm, neck of femur and fractured wrist. The resident was taken to the emergency room where the treatment was given for right side fractured wrist, laceration in arm and leg pain. After the incident the device was examined by arjohuntleigh representative. It was found it to be in good working condition with only minor wear and tear that would not influence its functionality. Following the event description, the exact sequence of events that lead to the resident's fall could not be stated with certainty. When looking at the design of the sara stedy, it is unlikely to fall out of the equipment when the resident is securely seated and supported by: knee pad (supporting the legs from the front) side frame (preventing the resident from falling sideways) and the seat (under the buttocks, supporting the resident body weight). The complaint history analysis showed a limited number of cases where the patient fell out sidewise during the transfer, before seat halves were secured, but the investigated complaint is the first case when it happened afterwards (without device tipping). The exact sequence of activities is unknown, and arjohuntleigh representative who interviewed the customer could not state how the resident could fall out without tipping the device. Some speculation was given that she may have tried to reach over to get something from the wardrobe or she stood up before falling but none of these scenarios could be confirmed as the caregiver turned around. The instructions for use (ifu, document number 001-12325 en rev. 2 dated on december 2011) in a detailed way describes how to safely operate the device. The following is included: "this mobile patient lift must be used by a caregiver trained with these instructions and qualified to work with the patient to be transferred and should never be used by patients on their own. " leaving the patient unattended, as described above, may be considered as not following the guidelines presented in the ifu. The mobility of the patient also could not be confirmed. It is known that she was suffering a right side weakness. According to the ifu: "this lift is intended to be used only by patients who have the ability to stand unaided or who can stand with minimal assistance. " "warning: before attempting a transfer, a clinical assessment of the patient's suitability for transfer should be carried out by a qualified health professional considering that, among other things, the transfer may induce substantial pressure on the patient's body. " even though the customer did not confirm details of medical condition of the resident, looking into complaints history it can be stated that using the device by residents who were not assessed properly could lead to the fall. The customer will be asked by arjohuntleigh sales representative to reassess the patient for suitability with sara stedy when she gets recovered to prevent similar incidents from recurring. What is more, sara stedy could be equipped with sling, which is optional and dependent on patient assessment. According to the ifu: "use of this accessory is recommended where the patient would benefit from extra confidence and support. " during the unfortunate transfer, the sling was not used, but looking at the outcome, it should be considered to use the sling in the future transfers of this resident. From the information collected to date, we came to a conclusion that the most likely cause of the incident was lack of a proper carefulness during patient's transfer and/or failure to assess the patient properly for transfer with sara stedy, which resulted in the patient's fall to the floor. It seems that the failure to follow safety instructions and recommendation included in the device instruction for use was a primary cause of the event occurrence. If that element of use error was not in place, the event could probably have been prevented. The device was up to manufacturer's specification during the event occurrence - no malfunction was recorded; the lift was used for patient handling and in that way it played a role in this event.
Patient Sequence No: 1, Text Type: N, H10
[74716829]
Arjohuntleigh received information about incident where it was reported that the resident was transferred from bed to sara stedy with assistance of two caregivers. While one of the caregivers was moving the patient on sara stedy towards the wardrobe and turning to open the door, the resident fell to the right side to the floor. Both caregivers immediately came to the resident and called for help. The resident already had a subdural hematoma and suffered with weakness on her right side. As an outcome of the incident, the patient sustained laceration of arm, neck of femur and fractured wrist. The resident was taken to the emergency room where the treatment was given for right side fractured wrist, laceration in arm and leg pain.
Patient Sequence No: 1, Text Type: D, B5
[117728956]
This is a follow-up 2 report to the follow-up 1 report (manufacturer report number: 9681684-2017-00029) that was submitted on 2017-apr-28. Arjohuntleigh collected the new information concerning the circumstances of the event. The following facts were gathered. 1. The patient was a long term resident at the facility (10 years) who had been using the stedy/sara stedy for several years. Both the patient and the staff members were familiar with the device, and there had been no previous indications of any issues related to appropriate use. It was a normal morning, normal routine, normal behaviours noted. The caregivers were permanent members of staff with latest in-house manual handling training completed in january 2017. They were very familiar with the patient, her routines and the sara stedy device. 2. Regular review of the patient's care plan were completed by the customer in line with requirement, latest risk assessment reviews had taken place in february 2017. Staff members were also familiar with continuous risk assessments based on patient needs. 3. Two caregivers were with the patient at the time of the incident so supervision was in place. The customer stated that one caregiver was making the bed. At the same time, the other caregiver moved the patient on the sara stedy, and turned to open the wardrobe door while maintaining contact with the device with one hand when the incident occurred. 4. Detailed and thorough internal investigation has been completed by the customer who was unable to determine specific root cause of the incident, although several recommendations were highlighted to prevent re-occurrence. In the light of those facts, we have re-evaluated the root cause of the event and the following have been established. 1. The staff was well trained and familiar with the equipment, so the wrong operating technique could be ruled out as a potential root cause. 2. It was confirmed that the patient was properly assessed as being suitable for transfer with sara stedy. 3. We can assume that the resident was under continuous supervision even though she was not observed all the time. 4. Due to limited information regarding the event immediate to the fall, the actual cause could not be determined. The customer has been made aware and agreed with the manufacturer's recommendations regarding continuous patient's assessment, following the instructions for use guidelines and also considering using the sling, which is optional accessory. Looking at the complaint history and our product knowledge, the most common causes of the patient's falls include bad condition of the device, wrong patient assessment or improper operating technique; however none of these factors seem to apply in this case. Having a confirmation that the equipment was in full working order and up to manufacturer's specification at the time of the incident, with reference to product safety based on appropriate patient assessment and equipment use in accordance with the device instructions for use, we find it to be unlikely that such event could re-occur. The device was up to manufacturer's specification during the event occurrence - no malfunction was recorded; the lift was used for patient handling and in that way it played a role in this event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9681684-2017-00029 |
| MDR Report Key | 6489292 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-04-13 |
| Date of Report | 2017-06-30 |
| Date of Event | 2017-02-28 |
| Date Facility Aware | 2017-03-24 |
| Report Date | 2017-06-30 |
| Date Reported to FDA | 2017-06-30 |
| Date Reported to Mfgr | 2017-06-30 |
| Date Mfgr Received | 2017-06-22 |
| Device Manufacturer Date | 2013-10-22 |
| Date Added to Maude | 2017-04-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. KINGA STOLINSKA |
| Manufacturer Street | KS. WAWRZYNIAKA 2 |
| Manufacturer City | KOMORNIKI, 62-052 |
| Manufacturer Country | PL |
| Manufacturer Postal | 62-052 |
| Manufacturer Phone | 98282467 |
| Manufacturer G1 | ARJOHUNTLEIGH MAGOG INC. |
| Manufacturer Street | 2001, TANGUAY |
| Manufacturer City | MAGOG, J1X 5Y5, |
| Manufacturer Country | CA |
| Manufacturer Postal Code | J1X 5Y5, |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SARA STEDY |
| Generic Name | CHAIR, WITH CASTERS |
| Product Code | INM |
| Date Received | 2017-04-13 |
| Model Number | NTB2000 |
| Operator | OTHER CAREGIVERS |
| Device Availability | Y |
| Device Age | 3 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARJOHUNTLEIGH MAGOG INC. |
| Manufacturer Address | 2001, TANGUAY MAGOG, J1X 5Y5, CA J1X 5Y5, |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2017-04-13 |