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 2017-01-27 for KINAIRMEDSURG manufactured by Arjohuntleigh, Inc..
[65905414]
(b)(4). A review of complaints related to various issue with side rails revealed that there are a few complaints (including this investigated) which concern patient fall due to the side rails failure or side rail detachment. Detailed review revealed that the investigated complaint is the first one with the scenario, where screw became loose due to the constant force applied resulting in side rail detachment and patient fall. The trend for side rail failure mode is decreasing. The product involved in the incident is a kinair medsurge bed, serial number: (b)(4). The device is customer-owned, sold to the (b)(6) care and rehabilitation center. The kinair medsurge system is designed with four side rails: two on each side of the bed. In the down position the side rail fold under the frame. The caregiver can slide the side rails from underneath the frame and rotate the side rails in the upper position. The side rails will lock automatically at half way; in order to continue the elevation of the side rail in the higher position, the caregiver must push the latch again and rotate further until the side rail is locked in the full up position. Upon the device inspection it was found that one of the two bolts that hold side rail detached from the bed frame. Over a time vibration caused by such situation led to wear through the threads of the second bolt. The bold/screw became worn completely smooth and was not holding to the bed frame. Based on the information collected to date and the result of the device evaluation conducted after return of the unit to the service center, we have been able to confirm the alleged malfunction - the screw was loose detaching the right-head rail off the bed frame. It was reported by the customer that a patient fell from kinair medsurge after leaning on the rail over a period of time and in a result the patient suffered a broken femur. According to the customer, the side rails were constantly subjected to physical force from the patient. It was communicated that the patient routinely reposition herself on the bed using the side rails as a support. In such situation the screws come loose or detached due to the repeated force applied on the side rails. The bed was being maintained by a third party company - biomed. The last maintenance was held on 19-aug-2016. No device service history record was provided by the facility. For this reason it is unknown if the third party company verified the device in relation to loose screws. However, it was indicated that biomed company checked the 3 remaining beds owned by the facility after the even to verify the screws. Based on this, it can be assumed that this part of preventive maintenance, which was indicated in internal arjohuntleigh documentation, was not performed previously. User manual # 201500-ah rev. A recommends "that all preventive and battery maintenance procedures be performed only by qualified arjohuntleigh service personnel or arjohuntleigh-approved personnel". In summary, the device failed to meet its specification. A part was worn in a way that would not hold side rail in place causing its detachment. The patient fell from kinair medsurge and in a result suffered a broken femur. The device was used at that time for treatment and therefore did play a role in the event. There are two factors which might contribute to the side rail failure, which resulted in patient fall: constant force applied to the side rails by the patient and incomplete preventive maintenance performed by a third party company. For this reason and taking into consideration all the circumstances of the reported event, the root cause may be defined as use error. Given the circumstances, we shall continue to monitor for any further events of this nature and do not propose any further action at this time.
Patient Sequence No: 1, Text Type: N, H10
[65905415]
The patient fell from kinair medsurge after leaning on the rail over a period of time and in a result the patient suffered a broken femur. It was stated that the screw was loose detaching the right-head rail off. The patient had fracture immobilized, administered pain control and applied dvt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007420694-2017-00021 |
| MDR Report Key | 6282307 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2017-01-27 |
| Date of Report | 2017-01-27 |
| Date of Event | 2016-12-26 |
| Date Mfgr Received | 2016-12-28 |
| Date Added to Maude | 2017-01-27 |
| 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, INC. |
| Manufacturer Street | 4958 STOUT DRIVE |
| Manufacturer City | SAN ANTONIO TX 78219 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 78219 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KINAIRMEDSURG |
| Generic Name | BED, FLOTATION THERAPY, POWERED |
| Product Code | IOQ |
| Date Received | 2017-01-27 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARJOHUNTLEIGH, INC. |
| Manufacturer Address | 4958 STOUT DRIVE SAN ANTONIO TX 78219 US 78219 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-01-27 |