MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-01-22 for PERMOBIL C500 N/A manufactured by Permobil Inc..
[184124448]
Report was received where the elevator had detached from its mounting position and allowed the seating to fall forward until the footplates rested against the ground. Reports indicate the end-user remained in the seating throughout the event. No injuries were sustained as a result of this occurrence. Inspection of the device shown the upper mounting hardware, m8 x 16mm (2ea), had, over time, loosened and fallen out. With the loss of the upper mounting hardware to secure the elevator in place, this allowed the seating system to fall forward due to loss of proper securement. Review of device history indicates service had been performed on this device at various times throughout the life of the device with notes of the elevator having been replaced, by the dealer, in 2015. It remains unclear if when the last service was performed, the hardware was checked for proper securement and torque specifications. Capa (b)(4) was opened to further investigate root cause, correct and monitor effectiveness. Provider reports having replaced the elevator and hardware with new and installed with the prescribed torque parameters. Device was returned to the end-user with no further issues being noted. The dhr was reviewed and the device met specification prior to distribution.
Patient Sequence No: 1, Text Type: N, H10
[184124449]
Received report of hardware which secures the elevator to the chassis having loosened and fallen out. This allowed the seating, with the end-user seated, to fall forward to where the footplates contacted the ground. Reports indicate the end-user remained in the seating and no injuries were reported to have occurred as a result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221084-2020-00001 |
| MDR Report Key | 9616044 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-01-22 |
| Date of Report | 2020-01-22 |
| Date of Event | 2019-12-26 |
| Date Mfgr Received | 2019-12-26 |
| Device Manufacturer Date | 2014-04-30 |
| Date Added to Maude | 2020-01-22 |
| 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 C500 |
| Generic Name | POWERED WHEELCHAIR |
| Product Code | ITI |
| Date Received | 2020-01-22 |
| Model Number | C500 |
| 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 DR. LEBANON TN 37090 US 37090 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-22 |