FDA Adverse Event
Malfunction
Summary report: N
QUICKIE Q7
MDR report key: 3252340
·
Received July 24, 2013
Report
- Report Number
- 2937137-2013-00022
- Event Type
- Malfunction
- Date Received
- July 24, 2013
- Date of Event
- June 26, 2013
- Report Date
- June 26, 2013
- Manufacturer
- SUNRISE MEDICAL (US) LLC.
- Product Code
- IOR
- PMA / PMN Number
- K973673
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, 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 REC'D, OUR INTERNAL FAILURE INVESTIGATOR WILL COMPLETE THE INVESTIGATION AND A F/U REPORT WILL BE FILED.
Description of Event or Problem · 1
DEALER REPORTED TO SUNRISE MEDICAL ON (B)(6) 2013 THAT THE END USER WAS GOING DOWN A RAMP WHEN THE LEFT CASTER FORK BROKE. THE DEALER ALLEGES THAT THE BREAK IS NEAR OR AT THE AXLE AREA OF THE FORK. THERE WERE NO INJURIES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 346037 | QUICKIE Q7 | WHEELCHAIR, MECHANICAL | IOR | SUNRISE MEDICAL (US) LLC. | EIR4 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 YR |