FDA Adverse Event
Malfunction
Summary report: N
NON AC-POWERED PATIENT LIFT
MDR report key: 3081505
·
Received April 29, 2013
Report
- Report Number
- 3004493922-2013-00930
- Event Type
- Malfunction
- Date Received
- April 29, 2013
- Report Date
- April 3, 2013
- Manufacturer
- INVACARE SUZHOU
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
(B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED.THE END USER ALLEGED THAT THE PUMP IS NOT STAYING UP. HE STATES THAT WHEN HE IS IN THE LIFT, IT WILL START TO COME DOWN. MDR FILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 185795 | NON AC-POWERED PATIENT LIFT | 880.5510 | FSA | INVACARE SUZHOU | 9805 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |