FDA Adverse Event
Malfunction
Summary report: N
NON AC-POWERED PATIENT LIFT
MDR report key: 3944130
·
Received July 18, 2014
Report
- Report Number
- 9616091-2014-01232
- Event Type
- Malfunction
- Date Received
- July 18, 2014
- Report Date
- June 11, 2014
- Manufacturer
- INVAMEX
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
DEALER REPORTS THE NEW BATTERIES WERE PUT IN NEW AND THE BEEPING STOPPED. THEY TESTED THE DEVICE WITH WEIGHT AND THERE WAS NO MOVEMENT THAT WAS NOT DIRECTED BY THE REMOTE.
Description of Event or Problem · 1
DEALER STATES THE DEVICE WAS RAISING AND LOWERING ON ITS OWN. THE DEVICE WAS ALSO BEEPING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 422719 | NON AC-POWERED PATIENT LIFT | 880.5510 | FSA | INVAMEX | RPL450-1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |