FDA Adverse Event
Malfunction
Summary report: N
VIKING
MDR report key: 2011876
·
Received March 3, 2011
Report
- Report Number
- 8030916-2011-00009
- Event Type
- Malfunction
- Date Received
- March 3, 2011
- Date of Event
- January 19, 2011
- Report Date
- February 10, 2011
- Manufacturer
- LIKO AB
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE INSTRUCTION GUIDE FOR THE LIFT STATES: BEFORE LIFTING ALWAYS MAKE CERTAIN THAT THE SLING'S STRAP LOOPS ARE CORRECTLY FASTENED TO THE SLINGBAR HOOKS WHEN THE SLING STRAP IS EXTENDED, BUT BEFORE THE PATIENT IS LIFTED FROM THE UNDERLYING SURFACE.
Description of Event or Problem · 1
FACILITY ALLEGED THAT WHILE TRANSFERRING A PATIENT THAT THE SHOULDER STRAP LOOP ON THE SLING BECAME DETACHED FROM SLING BAR. PATIENT WAS NOT INJURED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VIKING | NON-AC POWERED PATIENT LIFT | FSA | LIKO AB | VIKING XL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 14 YR |