BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOLVO 7007 ES

    MDR report key: 2821175 · Received October 30, 2012

    Report

    Report Number
    8030916-2012-00098
    Event Type
    Malfunction
    Date Received
    October 30, 2012
    Date of Event
    September 30, 2012
    Report Date
    October 9, 2012
    Manufacturer
    LIKO AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DISTRIBUTOR FOUND THAT THE STRAP WAS NOT PROPERLY CONNECTED TO THE SLING BAR WHICH LED TO THE SAFETY LATCH ON THE SLING BAR POPPING OFF WITH THE STRAP. THE SAFETY CLIP WAS REINSTALLED, TESTED AND THE LIFT WAS FOUND OPERATIONAL. THE CAREGIVERS WERE INSTRUCTED ON THE PROPER USE OF THE LIFT, USING THE SLING WITH THE SLING BAR AND HOW THE SLING MUST BE IN THE PROPER LOCATION ON THE SLING BAR BEFORE LIFTING A PT.

    Description of Event or Problem · 1

    THE COMPLAINANT STATED WHEN THE CAREGIVER STARTED TO MOVE THE LIFT TO POSITION A RESIDENT OVER THE CHAIR, ONE OF THE SAFETY LATCHES ON THE SLING BAR POPPED OFF ALONG WITH ONE OF THE STRAPS. THE STAFF IMMEDIATELY ATTENDED TO THE RESIDENT, USING THE LIFT TO LOWER THE RESIDENT SAFELY TO THE FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GOLVO 7007 ES LIFT, PATIENT, NON-AC-POWERED FSA LIKO AB 2000010

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK