MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-04 for PERMOBIL M3 N/A manufactured by Permobil Inc..
[184128909]
Inspection indicates a weldment point on the recline actuator mounting bracket having broken away. This weldment is where the recline actuator is secured, and in whole, is attached to the seat frame. It was reported when this component broke, it allowed the back hinge to no longer remain upright as the recline actuator was no longer secured. No injury was reported to have occurred as a result of this event. This is a known failure mode and following an investigation, permobil concluded no unusual or significant deterioration of the components were detected. The recline actuator and suspect bracket met acceptable performance margins and replacement components were approved for distribution. The service provider was supplied approved parts with the repair of the device being completed and returned to the end-user. Note: to assess the full impact of this failure mode, capa (b)(4) has been opened to further investigate, correct and monitor effectiveness. The dhr for this device has been reviewed and the wheelchair met specification prior to distribution.
Patient Sequence No: 1, Text Type: N, H10
[184128910]
Received report claiming as the end-user had completed a tilt function, the backrest reportedly gave way. It was reported the end-user noticed something was wrong and caught themselves before the backrest fell. No injuries were reported to have been sustained as a result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221084-2020-00012 |
| MDR Report Key | 9788167 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-03-04 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-02-08 |
| Date Mfgr Received | 2020-02-10 |
| Device Manufacturer Date | 2017-10-13 |
| Date Added to Maude | 2020-03-04 |
| 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 | MR. KEVIN BULLOCK |
| Manufacturer Street | 300 DUKE DRIVE |
| Manufacturer City | LEBANON, TN |
| Manufacturer Country | US |
| Manufacturer Phone | 7360925451 |
| Manufacturer G1 | PERMOBIL INC. |
| Manufacturer Street | 300 DUKE DRIVE |
| Manufacturer City | LEBANON, TN |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERMOBIL M3 |
| Generic Name | POWERED WHEELCHAIR |
| Product Code | ITI |
| Date Received | 2020-03-04 |
| Model Number | M3 |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PERMOBIL INC. |
| Manufacturer Address | 300 DUKE DRIVE LEBANON, TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-04 |