BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTALLIFT -EPL

    MDR report key: 1277305 · Received December 31, 2008

    Report

    Report Number
    MW5009504
    Event Type
    Injury
    Date Received
    December 31, 2008
    Date of Event
    December 7, 2008
    Report Date
    December 31, 2008
    Manufacturer
    WY-EAST MEDICAL CORP.
    Product Code
    FNG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS BEING LIFTED FROM THE FLOOR WITH THE TOTALLIFT -EPL. THE STRAP GOT CAUGHT UNDER THE LEG OF THE EQUIPMENT. THE PT EXPERIENCED SOME RESPIRATORY DISTRESS WHILE IN THE LIFT. THE EMERGENCY RELEASE DOWN BUTTON FAILED TO WORK. STAFF HAD TO REMOVE THE SLING TO GET PT OUT OF LIFT. THE PT THEN EXPERIENCED A RESPIRATORY AND CARDIAC ARREST. RESUSCITATION WAS SUCCESSFUL AT THAT TIME. INITIAL CHECKING OF THE EQUIPMENT COULD NOT DUPLICATE THE FAILURE. IN LATE 2008, OUR BIOMED DEPT PERFORMED A SECOND TEST ON THE EQUIPMENT AND AT THAT TIME THE EMERGENCY RELEASE DOWN BUTTON DID NOT FUNCTION. DATES OF USE: 2006 - 2008. DIAGNOSIS OR REASON FOR USE: PT LIFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTALLIFT -EPL PATIENT LIFT FNG WY-EAST MEDICAL CORP. VL-620

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Life Threatening