BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOYER LIFT

    MDR report key: 1070702 · Received July 2, 2008

    Report

    Report Number
    2182305-2008-00029
    Event Type
    Other
    Date Received
    July 2, 2008
    Date of Event
    June 7, 2008
    Report Date
    June 23, 2008
    Manufacturer
    APEX HEALTHCARE MFG INC.
    Product Code
    FNG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO DISTRIBUTOR BY FACILITY; PER FACILITY, THEY WERE TRANSFERRING A RESIDENT FROM THE BATH TUB TO THE WHEELCHAIR, WHEN THE SWIVEL PIN BROKE. WHEN THIS SWIVEL PIN BROKE, THE RESIDENT FELL TO THE FLOOR AND BROKE HIS LEG. ONE PERSON WAS PRESENT AT TIME OF SAID INCIDENT. FACILITY HAS TWO LIFTS OF THIS KIND IN THEIR FACILITY AND THEY ARE REQUESTING MFR TO COME AND INSPECT, THEN REPLACE BOTH OF THE LIFTS. PER FACILITY THEY DO NOT TRUST THE SECOND LIFT BECAUSE OF THE INCIDENT THAT OCCURRED WITH THE FIRST LIFT. MFR TO REPLACE THE LIFT INVOLVED IN THE ALLEGED INCIDENT AND WILL BE SENDING IN EMSAR, OUR SERVICE TEAM, TO INSPECT THE SECOND LIFT. RMA ISSUED TO GET LIFT BACK IN QUESTION FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOYER LIFT PATIENT LIFTER FNG APEX HEALTHCARE MFG INC. HOY-PRESENCE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other