BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOLVO

    MDR report key: 2243495 · Received August 19, 2011

    Report

    Report Number
    8030916-2011-00053
    Event Type
    Malfunction
    Date Received
    August 19, 2011
    Date of Event
    May 2, 2011
    Report Date
    August 1, 2011
    Manufacturer
    LIKO AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    PER INFO PROVIDED BY LOCAL DISTRIBUTOR - THE NURSE WAS LIFTING A PT WITH THE SLING BAR MISSING THE SAFETY CLIPS. SHE DID NOT LET BIOMED AT THE FACILITY KNOW OF THIS ISSUE BEFORE THE TRANSFER. THE PT WAS NOT INJURED BUT WANTED TO ADVISE MFR OF THIS PROBLEM. NURSE UNDERSTANDS SHE DID NOT FOLLOW PROPER LIFTING PROCEDURES. FACILITY STAFF FURTHER CLAIMED THAT THE SAFETY CLIPS ON THE SLING BAR ARE EASY TO FALL OUT. FACILITY BIOMED HAS REPLACED SAFETY CLIPS ON ALL SLING BARS TO PREVENT FUTURE POTENTIAL ISSUES. LOCAL DISTRIBUTOR PERFORMED IN-SERVICE FOR STAFF AT THE FACILITY TO ENSURE PROPER TRANSFER TECHNIQUES ARE USED. SAFETY INSTRUCTIONS CLEARLY STATE: BEFORE LIFTING ALWAYS MAKE CERTAIN THAT (AMONG OTHER POINTS): LIFTING ACCESSORIES ARE NOT DAMAGED.

    Description of Event or Problem · 1

    FACILITY COMPLAINT RECEIVED THAT THE LATCHES AT EITHER END OF THE SLING BAR BREAK OFF VERY EASILY. NO INJURY ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GOLVO NON-AC POWERED PT LIFT FSA LIKO AB GOLVO 7007 ES

    Patients

    Seq Age Sex Outcome Treatment
    1