MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2017-04-11 for SARA STEDY NTB2000 manufactured by Arjohuntleigh Magog Inc..
[72330788]
(b)(4). Additional information will be provided upon conclusion of the manufacturer's investigation.
Patient Sequence No: 1, Text Type: N, H10
[72330789]
Arjohuntleigh was informed about an incident which occurred during the use of sara stedy active lift. It was indicated that during transfer from chair to sara stedy, patient stood up and then fell. The caregiver used sara plus to lift the resident and noticed the leg fracture. As a result, the patient required surgery of broken femur.
Patient Sequence No: 1, Text Type: D, B5
[77953755]
An investigation was carried out into this complaint. Arjohuntleigh was informed about an event which occurred in (b)(6) hospital in (b)(6). Following the information reported, a patient who was going to be transferred to the restroom with staff assistance has experienced an unforeseen orthostatic hypotensive event upon standing. This condition led to patient's fall. When the caregiver attempted to lift the resident, a leg fracture was noticed. The patient had a broken femur which required further medical intervention - a surgery was performed. The lift was withdrawn from use and evaluated by arjohuntleigh representative after the event. The device was found in the excellent condition, fully functional. When reviewing similar reportable events with the involvement of the sara stedy it was possible to determine a number of events presenting a similar scenario covering patient's fall. The occurrence rate observed for this failure mode is currently considered to be very low. The sara stedy is a mobile active lift intended to be operated on horizontal surfaces for transferring patients and residents in hospitals, nursing homes or other health care facilities. It is suitable for transferring patient to/from a chair, a wheelchair, a bed and a toilet. Basing on the information gathered, it appears most likely that the patient has fallen down unexpectedly, during the attempt to stand up. Patient has experienced an unforeseen weakness which led to a lower ability of self-support. This impacted the required level of mobility to continue the transfer procedure. As the sequence of events was dynamic (the patient has lost his balance shortly after standing up), the fall was not avoided by the caregiving staff despite alleged proper patient's clinical assessment. The instructions for use (ifu 001-12325 en, feb 2014) clearly defines procedure of safe lift operation. Several recommendations and warnings were issued by arjohuntleigh in order to assure the safety of usage: "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. " "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. " device instructions leave it for the caregiving staff to evaluate patient's condition and their suitability for the transfer. The number of staff to assist the transfer and patient's medical evaluation plays a significant role in the process - it allows to securely conduct the procedure, involving all necessary features. Nevertheless, it appears possible that some unforeseen changes of health condition may occur at every stage of the transferring process and significantly impact it, depending on the nature of the event. As a medical history of the resident or detailed information regarding his health state prior or after the event was not provided, it is not possible to exclude the potential scenario of some use error aspects (elements of an incorrect assessment) contributing to the outcome of the event. Following technical evaluation of the device, when the resident fell down, arjohuntleigh system met its performance specifications and performed as intended. Basing on the information gathered, it is considered most likely that the unfortunate sequence of events determined by patient's condition have led to the accidental fall of a patient experiencing unforeseen orthostatic hypotensive condition, which resulted in serious health consequence. Due to the nature of this incident we are reporting this event to competent authorities taking into consideration a serious outcome of the incident. It has been established that sara stedy was in use for a patient treatment at the time of the event but our review did not identify any direct indication of its contribution to the outcome of the event. Based on the above, the device was found not to have malfunctioned (was performing up to the specification) when the event took place.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9681684-2017-00026 |
| MDR Report Key | 6479554 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2017-04-11 |
| Date of Report | 2017-05-26 |
| Date of Event | 2017-03-12 |
| Date Facility Aware | 2017-03-14 |
| Report Date | 2017-05-26 |
| Date Reported to FDA | 2017-05-26 |
| Date Reported to Mfgr | 2017-05-26 |
| Date Mfgr Received | 2017-04-27 |
| Device Manufacturer Date | 2016-11-15 |
| Date Added to Maude | 2017-04-11 |
| 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 | UL. KS. PIOTRA 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 |
| 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 | 2017-04-11 |
| Model Number | NTB2000 |
| Operator | OTHER CAREGIVERS |
| Device Availability | Y |
| Device Age | 4 MO |
| 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; 2. Required No Informationntervention | 2017-04-11 |