MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-01-31 for PERMOBIL F5 N/A manufactured by Permobil Inc..
[184109621]
The end-user reported they had just come to the bottom of the ramp that leads from their home to an outdoor screened porch when the device reportedly continued to drive. The end-user claimed they had removed their hand from the joystick, but the device continued to drive until it impacted with the aluminum siding of the screened room. Report claimed the end-user had re-injured a toe on their left foot which had been broken previously from an similar incident approximately 2 weeks prior. The previous event was never reported to permobil, but description of that event was identical in every respect in that it occurred in the same location with the same allegation of continued drive with collision into screen porch aluminum structure. Service provider stated they did not report the original incident to permobil as they considered that event as use error. Provider reports having evaluated the device finding no issues that would indicate a product malfunction having occurred. After receiving a second report of failure to stop, permobil was notified. The device was re-evaluated after the second reported event to which the device was again found to be fully operational with the device coming to a full and complete stop each time the joystick was released. Multiple attempts to recreate the reported anomaly were conducted to which the device operated normally without any deviation or hesitation in drive controls. No reports were relayed to the provider of the device having operated abnormally, in any other situation or location, other than the 2 instances reported having occurred at the same location. The device was inspected and found to be in proper working condition with no notable deficiencies. The dhr was reviewed and the device met specification prior to distribution.
Patient Sequence No: 1, Text Type: N, H10
[184109622]
Received report as end-user was driving down a ramp from a 3" rise, the device was reported to have continued to drive after the end-user had removed their hand from the joystick. Reports allege the chair failed to stop and continued forward causing the end-users footplates to contact an aluminum wall of a screen porch. Report indicated the end-user re-injured his toe from a previous (non reported) incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221084-2020-00002 |
| MDR Report Key | 9655874 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-01-31 |
| Date of Report | 2020-01-31 |
| Date of Event | 2020-01-06 |
| Date Mfgr Received | 2020-01-07 |
| Device Manufacturer Date | 2016-08-15 |
| Date Added to Maude | 2020-01-31 |
| 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 37090 |
| Manufacturer Country | US |
| Manufacturer Postal | 37090 |
| Manufacturer Phone | 8007360925 |
| Manufacturer G1 | PERMOBIL INC. |
| Manufacturer Street | 300 DUKE DRIVE |
| Manufacturer City | LEBANON TN 37090 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 37090 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERMOBIL F5 |
| Generic Name | POWERED WHEELCHAIR |
| Product Code | ITI |
| Date Received | 2020-01-31 |
| Model Number | F5 |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PERMOBIL INC. |
| Manufacturer Address | 300 DUKE DRIVE LEBANON TN 37090 US 37090 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-01-31 |