BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVACARE LIFTS AND SLINGS

    MDR report key: 1073664 · Received July 9, 2008

    Report

    Report Number
    1525712-2008-00060
    Event Type
    Injury
    Date Received
    July 9, 2008
    Date of Event
    June 8, 2008
    Report Date
    July 7, 2008
    Manufacturer
    INVACARE CORPORATION - MANUFACTURING FACILITY
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT, AS RECEIVED, INDICATES THAT THE LOOP OF THE SLING SOMEHOW BECAME DETACHED FROM THE SPREADER BAR HOOK DURING TRANSFER OF THE PT. PROPERLY USED, SLING LOOPS WILL NOT COME OFF THE HOOK AS DESCRIBED. USER GUIDES ARE CLEAR IN INSTRUCTING AS TO THE PROPER AND SAFE USE OF THE PRODUCT. THIS INCIDENT IS VIEWED AS USER ERROR ISSUE AND NOT A PRODUCT PROBLEM. RETURN IS NOT ANTICIPATED, PRODUCT IS STILL IN USE.

    Description of Event or Problem · 1

    TWO EMPLOYEES OF THE NURSING FACILITY PUT THE RESIDENT ON THE SLING AND HOOKED THE SLING TO THE LIFT. WHEN THEY LIFTED THE RESIDENT UP AND ATTEMPTED TO TRANSFER HER, THE LOOP THAT WAS NEAR HER HEAD ALLEGEDLY CAME OFF THE SWIVEL BAR, CAUSING HER TO FALL OUT AND FRACTURE HER COLLAR BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVACARE LIFTS AND SLINGS 880.5510 FSA INVACARE CORPORATION - MANUFACTURING FACILITY RPA600-1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention