FDA Adverse Event
Malfunction
Summary report: N
PRIDE MOBILITY PRODUCTS
MDR report key: 3252006
·
Received July 29, 2013
Report
- Report Number
- 2530130-2013-00055
- Event Type
- Malfunction
- Date Received
- July 29, 2013
- Date of Event
- July 19, 2013
- Report Date
- September 27, 2013
- Manufacturer
- PRIDE MOBILITY PRODUCTS
- Product Code
- ITI
- PMA / PMN Number
- K042612
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED AND EVALUATED. BASED ON THE PHYSICAL EVIDENCE OF ROTATIONAL STRIATIONS ON THE MOTOR CASE AND REMNANTS OF ROPE, IT IS THE EVALUATORS OPINION THAT THE MOTOR LIKELY FAILED DUE TO SOMETHING BEING CAUGHT IN THE DRIVE WHEEL AXLE.
Additional Manufacturer Narrative · 1
THE DEVICE IS NOT AVAILABLE FOR EVALUATION AT THIS TIME. SHOULD FURTHER INFORMATION OR THE DEVICE BECOME AVAILABLE, A FOLLOW-UP REPORT WILL THEN BE ISSUED.
Description of Event or Problem · 1
DEALER ALLEGES CHAIR HAD A BURNING SMELL AND SMOKE COMING FROM IT.
Description of Event or Problem · 1
DEALER ALLEGES CHAIR HAD A BURNING SMELL AND SMOKE COMING FROM IT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 352696 | PRIDE MOBILITY PRODUCTS | POWERED WHEELCHAIR | ITI | PRIDE MOBILITY PRODUCTS | Q6 EDGE | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening |