FDA Adverse Event
Malfunction
Summary report: N
QUICKIE Q7
MDR report key: 3657741
·
Received November 14, 2013
Report
- Report Number
- 2937137-2013-00059
- Event Type
- Malfunction
- Date Received
- November 14, 2013
- Date of Event
- October 30, 2013
- Report Date
- October 30, 2013
- Manufacturer
- SUNRISE MEDICAL (US) LLC.
- Product Code
- IOR
- PMA / PMN Number
- K123975
- Product Problem
- Yes
- Report Source
- Manufacturer report
- 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 INVESTIGATOR WILL COMPLETE THE INVESTIGATION AND A FOLLOW UP REPORT WILL BE FILED.
Description of Event or Problem · 1
A MALFUNCTION INVOLVING A QUICKIE Q7 WAS REPORTED TO SUNRISE MEDICAL ON (B)(4) 2013. IT WAS REPORTED TO SUNRISE MEDICAL THAT THE BACKREST BRACKETS HAD BROKEN. THERE WERE NO FALLS OR INJURIES REPORTED DUE TO THIS MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 591910 | QUICKIE Q7 | WHEELCHAIR, MECHANICAL | IOR | SUNRISE MEDICAL (US) LLC. | EIR4 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR |