MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-18 for F5 CORPUS VS N/A manufactured by Permobil Ab (pab).
[184126018]
The suspect component was returned to permobil ab for evaluation. Investigation concluded the sensor for the co-pilot was out of adjustment. Visual examination shown the handle was not in the proper level position needed for normal operation. Interviews with service personnel indicate during their initial evaluation to determine potential issue, they had misaligned the sensor prior to returning to permobil for inspection. With the co-pilot sensor being incorrectly adjusted, the chair may maneuver in a direction that is not desired when the co-pilot is activated. After repositioning the sensor to the correct position, the co-pilot control operated as per design specification with no notable issues. Permobil was unable to confirm the reported event was caused due to misalignment of the sensor in the co-pilot handle as component was reportedly altered prior to inspection. It remains unclear if the co-pilot control was misaligned during use by the attendant and/or inadvertent impacts to the co-pilot handle which could potentially force the sensor to become misaligned. The co-pilot control was replaced with new and device returned to the end-user with no further issues being reported. Follow-up instructions have been relayed to the caregivers as to the proper positioning and operation of the co-pilot control. The dhr was reviewed and device met specification prior to distribution.
Patient Sequence No: 1, Text Type: N, H10
[184126019]
Received report claiming while the end-user and device where inside an elevator, the attendant attempted to back the device up via the co-pilot attendant control. Reports claim the device drove forward instead of backward subsequently running the device into the elevator wall, pinching the end-users foot. No serious injuries to the end-user were sustained.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221084-2020-00010 |
| MDR Report Key | 9722885 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-02-18 |
| Date of Report | 2020-02-18 |
| Date of Event | 2020-01-22 |
| Date Mfgr Received | 2020-01-22 |
| Device Manufacturer Date | 2019-09-30 |
| Date Added to Maude | 2020-02-18 |
| 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 AB |
| Manufacturer Street | PER UDDENS VAG 20 |
| Manufacturer City | TIMRA, 861 23 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | 861 23 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | F5 CORPUS VS |
| Generic Name | POWERED WHEELCHAIR |
| Product Code | ITI |
| Date Received | 2020-02-18 |
| Returned To Mfg | 2020-01-28 |
| Model Number | F5 CORPUS VS |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PERMOBIL AB (PAB) |
| Manufacturer Address | PER UDDENS VAG 13 TIMRA, 861023 SW 861023 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-18 |