FDA Adverse Event
Malfunction
Summary report: N
NON AC-POWERED PATIENT LIFT
MDR report key: 2991889
·
Received March 6, 2013
Report
- Report Number
- 3004493922-2013-00540
- Event Type
- Malfunction
- Date Received
- March 6, 2013
- Report Date
- February 11, 2013
- Manufacturer
- INVACARE SUZHOU
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
(B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. PER DEALER PUMP WILL NOT STAY UP AND IS LEAKING INSIDE. MDR FILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 96341 | NON AC-POWERED PATIENT LIFT | 880.5510 | FSA | INVACARE SUZHOU | 9805P |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |