MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-15 for QUICKIE PULSE 5 POWERCHAIR PLS5A-114217 manufactured by Sunrise Medical (us) Llc.
[175730241]
Due to wheelchair footplates fourth failure, fell to floor transferring. Four months without working footplates. (b)(6) came due to fall. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092274 |
| MDR Report Key | 9595972 |
| Date Received | 2020-01-15 |
| Date of Report | 2020-01-13 |
| Date of Event | 2019-12-29 |
| Date Added to Maude | 2020-01-16 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | QUICKIE PULSE 5 POWERCHAIR |
| Generic Name | WHEELCHAIR, POWERED |
| Product Code | ITI |
| Date Received | 2020-01-15 |
| Model Number | PLS5A-114217 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SUNRISE MEDICAL (US) LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-15 |