BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GH3

    MDR report key: 9646670 · Received January 30, 2020

    Report

    Report Number
    9646670
    Event Type
    Malfunction
    Date Received
    January 30, 2020
    Date of Event
    January 11, 2020
    Report Date
    January 22, 2020
    Manufacturer
    V. GULDMANN A/S
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS INITIALLY POSITIONED WITH LIFT SLING UNDERNEATH PATIENT AND THEN PATIENT WAS CONNECTED TO OVERHEAD LIFT VIA STRAPS ON SLING. ALL STRAPS WERE IN POSITION AND IN SECURED AREAS FOR THE STRAPS. NEXT LIFT WAS ACTIVATED/ELEVATED AND PATIENT WAS ELEVATED ~2 INCHES ABOVE BED TO ENSURE PROPER PLACEMENT OF SLING. WHILE LOOKING FOR CORRECT FIT, SLING STRAP CAME OUT OF SECURED AREA ON OVERHEAD LIFT. PATIENT REMAINED CONTAINED IN SLING AND THEN IMMEDIATELY LOWERED BACK DOWN ONTO BED TO HAVE SLING REPOSITIONED AND CONNECTED TO LIFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110468 GH3 LIFT, PATIENT, NON-AC-POWERED FSA V. GULDMANN A/S

    Patients

    Seq Age Sex Outcome Treatment
    1 5110 DA