MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-02-19 for PERMOBIL M300 N/A manufactured by Permobil Inc..
[184127431]
Reports provided indicate the telescoping bars that secure the back frame to the seating having broken just above where they attach to the seat frame. Provider reports they were not informed as to the circumstances that led to the component failure, only that the back frame had broken and the end-user was not injured. This known failure mode was analyzed at the parent company in sweden and all parts met design specifications. It was, however noted, that this component had failed because it had seen unusual stress which allowed it to fatigue and break over time. It was decided in 4/2015 that the part could be changed to a different material that would be able to withstand more severe use and be less susceptible to fatigue. A new design of this part has been implemented into production as of 6/2015. The re-designed part has been issued to the service provider to address this reported failure. A corrective and preventative action (capa (b)(4)) has been implemented to investigate, correct, and monitor effectiveness. Dealer confirmed having received the new components, installed on the device and returned to end-user. The dhr for this device was reviewed and chair met specifications prior to distribution.
Patient Sequence No: 1, Text Type: N, H10
[184127432]
Received report of backrest canes having broken just above where they are secured to the seating. No information was provided as to the circumstances surrounding the reported failure. No injuries were reported to have occurred as a result of the component failure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221084-2020-00011 |
| MDR Report Key | 9729525 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-02-19 |
| Date of Report | 2020-02-19 |
| Date of Event | 2020-02-08 |
| Date Mfgr Received | 2020-02-10 |
| Device Manufacturer Date | 2015-01-30 |
| Date Added to Maude | 2020-02-19 |
| 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 M300 |
| Generic Name | POWERED WHEELCHAIR |
| Product Code | ITI |
| Date Received | 2020-02-19 |
| Model Number | M300 |
| 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 | 2020-02-19 |