BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERGOLIFT

    MDR report key: 1346932 · Received February 8, 2009

    Report

    Report Number
    9681684-2009-00010
    Event Type
    Malfunction
    Date Received
    February 8, 2009
    Date of Event
    December 7, 2008
    Report Date
    February 6, 2009
    Manufacturer
    BHM MEDICAL, INC.
    Product Code
    FNG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    THE FACILITY REPORTED THAT THE PATIENT WAS BEING LIFTED OFF THE FLOOR. THE STRAP GOT CAUGHT UNDER THE LEG OF THE EQUIPMENT. THE PATIENT EXPERIENCED SOME RESPIRATORY DISTRESS WHILE IN THE LIFT. THE EMERGENCY RELEASE DOWN BUTTON FAILED TO WORK. THE STAFF HAD TO REMOVE THE STRAP TO GET THE PATIENT OUT OF THE LIFT. THE PATIENT THEN EXPERIENCED A RESPIRATORY AND CARDIAC ARREST. RESUSCITATION WAS SUCCESSFUL AT THE TIME. THE PATIENT WAS A (B) (6) MALE WITH MULTIPLE MEDICAL PROBLEMS. HE SUBSEQUENTLY EXPIRED IN (B) (6) 2008 DUE TO HIS MEDICAL CONDITION, NOT RELATED TO USE OF THE LIFT. (B) (4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ERGOLIFT PATIENT LIFT FNG BHM MEDICAL, INC. ERGOLIFT 600

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR