FDA Adverse Event
Other
Summary report: N
GOLVO
MDR report key: 2475614
·
Received February 24, 2012
Report
- Report Number
- 8030916-2012-00020
- Event Type
- Other
- Date Received
- February 24, 2012
- Date of Event
- January 31, 2012
- Report Date
- January 31, 2012
- Manufacturer
- LIKO AB
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INSTRUCTION GUIDE FOR UNIVERSAL SLING BAR ((B)(4)) STATES: FOR SAFE AND TROUBLE-FREE OPERATION, A FEW ROUTINE PROCEDURES SHOULD BE PERFORMED EVERY DAY, BEFORE THE SLING BAR IS IN USE: WHEN USING A QUICK-RELEASE HOOK SYSTEM, CHECK THAT THE QUICK-RELEASE HOOK IS CORRECTLY FASTENED TO THE LIFT AND THE SLING BAR. INSTRUCTION GUIDE FOR THE LIFT ((B)(4)) STATES: BEFORE LIFTING ALWAYS MAKE CERTAIN THAT: THE LIFTING ACCESSORY IS CORRECTLY APPLIED TO THE LIFTING EQUIPMENT.
Description of Event or Problem · 1
ACCORDING TO STAFF AT THE FACILITY, THE RED CATCH LOCK ON THE QUICK RELEASE HOOK BROKE DURING A PT TRANSFER AND THE SLING BAR DETACHED FROM THE LIFT. PT ALLEGED BACK PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GOLVO | NON-AC POWERED PATIENT LIFT | FSA | LIKO AB | GOLVO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR |