FDA Adverse Event
Malfunction
Summary report: N
QUICKIE Q7
MDR report key: 3381847
·
Received September 3, 2013
Report
- Report Number
- 2937137-2013-00038
- Event Type
- Malfunction
- Date Received
- September 3, 2013
- Date of Event
- August 7, 2013
- Report Date
- August 7, 2013
- Manufacturer
- SUNRISE MEDICAL (US) LLC
- Product Code
- IOR
- PMA / PMN Number
- K973673
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
IT APPEARS THAT THE WHEELCHAIR AND/OR PARTS INVOLVED IN THIS INCIDENT ARE BEING RETURNED TO SUNRISE MEDICAL (US) LLC. IF AND WHEN THE CHAIR/PARTS ARE RECEIVED, OUR INTERNAL FAILURE INVESTIGATION WILL COMPLETE THE INVESTIGATION AND A F/U REPORT WILL BE FILED.
Description of Event or Problem · 1
A SUNRISE MEDICAL SALES REP REPORTED THAT THE END USER IS EXPERIENCING PROBLEMS WITH HIS WHEELCHAIR. IT WAS REPORTED TO SUNRISE MEDICAL THAT THE RIGHT BACK BRACKET BROKE WHILE THE END USER WAS RIDING HIS WHEELCHAIR OUTSIDE ON THE SIDEWALK. THERE WERE NO FALLS OR INJURIES REPORTED DUE TO THIS MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 436525 | QUICKIE Q7 | WHEELCHAIR, MECHANICAL | IOR | SUNRISE MEDICAL (US) LLC | EIR4 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |