FDA Adverse Event
Malfunction
Summary report: N
VIKING
MDR report key: 2243490
·
Received August 19, 2011
Report
- Report Number
- 8030916-2011-00058
- Event Type
- Malfunction
- Date Received
- August 19, 2011
- Date of Event
- August 2, 2011
- Report Date
- August 2, 2011
- Manufacturer
- LIKO AB
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
FACILITY COORDINATOR RELEASED THE E-STOP BUTTON ON THE LIFT AND THE HAND CONTROLLER BEGAN TO FUNCTION PROPERLY. ACTUATOR WAS REPLACED AND LIFT IS BACK IN SERVICE.
Description of Event or Problem · 1
CUSTOMER WAS LOWERING A PT AND THE HAND CONTROLLER DOWN BUTTON WAS NOT FUNCTIONING. CUSTOMER USED THE MANUAL EMERGENCY DOWN. THE ACTUATOR STOPPED JUST AN INCH ABOVE THE SHOWER CHAIR. LIFT WAS TAKEN OUT OF SERVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VIKING | NON-AC POWERED PATIENT LIFT | FSA | LIKO AB | VIKING L |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |