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 C300 N/A manufactured by Permobil Inc..
[184128046]
Evaluation of the device confirmed the top plate of the fixed seat tube having detached from the inner tube. Reports indicate the end-user did not incur any serious injuries during the event. The component failure is being attributed to stresses being applied over time leading to eventual material fatigue of the top plate. A corrective and preventative action (capa (b)(4)) has been implemented to investigate, correct, and monitor effectiveness. As a result of the capa investigation, it was decided that a thicker 8mm material be used for the top plate, replacing the current 6mm design. With this material design change, it was determined the change to the thicker material improved the overall strength of the component making it less susceptible to material fatigue when exposed to log term stresses. The redesigned component has been installed on the device, and the chair returned to the end-user. The dhr was reviewed and chair met specification prior to distribution.
Patient Sequence No: 1, Text Type: N, H10
[184128047]
Received report as end-user was in process of transferring into the seating, they noted the seating starting to move. Inspection indicated the upper plate of the fixed seat tube, which the seating is secured, had broken allowing the seating to move. No injuries were reported to have occurred as a result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221084-2020-00013 |
| MDR Report Key | 9788171 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-03-04 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-02-01 |
| Date Mfgr Received | 2020-02-10 |
| Device Manufacturer Date | 2014-11-26 |
| 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 C300 |
| Generic Name | POWERED WHEELCHAIR |
| Product Code | ITI |
| Date Received | 2020-03-04 |
| Model Number | C300 |
| 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 |