FDA Adverse Event
Malfunction
Summary report: N
POWER CHAIR 20 WIDE BY 18 DEEP FOR PMI
MDR report key: 5097649
·
Received September 23, 2015
Report
- Report Number
- 3008262382-2015-01734
- Event Type
- Malfunction
- Date Received
- September 23, 2015
- Date of Event
- August 18, 2015
- Report Date
- August 27, 2015
- Manufacturer
- INVACARE REHABILITATION EQUIPMENT CO.
- Product Code
- ITI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A SUPPLEMENTAL RECORD WILL BE FILED.
Description of Event or Problem · 1
PROVIDER STATES THE SEAT BRACKET IS BROKEN AND WILL NOT LOCK IN PLACE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 628845 | POWER CHAIR 20 WIDE BY 18 DEEP FOR PMI | WHEELCHAIR, POWERED | ITI | INVACARE REHABILITATION EQUIPMENT CO. | M51PSEMIBLUE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |