BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOYER LIFT

    MDR report key: 730387 · Received June 26, 2006

    Report

    Report Number
    2182305-2006-00023
    Event Type
    Other
    Date Received
    June 26, 2006
    Date of Event
    May 26, 2006
    Report Date
    June 12, 2006
    Manufacturer
    APEX HLTHCARE MFG INC
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO MFR BY END USER DAUGHTER; WHILE HER MOTHER WAS BEING TRANSFERRED BACK TO HER BED USING THE LIFT THE BOOM AND CRADLE SUDDENLY RELEASED AND DROPPED HER MOTHER DOWN ONTO HER BED. NO REPORTED INJURY. DAUGHTER AND MOTHER ARE REQUESTING ANOTHER UNIT AS THEY FEEL THE CURRENT UNIT IS NOT SAFE. AFTER MFR WAS IN CONTACT WITH THE DEALER., YANKEE MEDICAL, IT WAS DISCOVERED THIS UNIT WAS WITHIN THE SERIAL NUMBER RANGE INVOLVED IN THE HYD JACK RECALL (NUMBER Z-0904-06). DEALER HAS 31 UNITS WITHIN THE S/N RANGE OF SAID RECALL AND HAD NOT GONE OUT YET TO DO REPAIRS AND OR REPLACEMENTS. THEY WERE AWARE OF MFR FIRST AND SECOND MAILINGS ON THE LIFT / JACK ISUSE. MFR SENT REPLACEMENT JACK OUT TO END USER AND ISSUED RMA #673458 FOR RETURN AND EVALUATION. SERIAL NUMBER OF JACK COMPLAINT RECEIVED IS LIFT S/N 0310L1916 WITH JACK S/N 0310H1786, MFG DATE OF OCTOBER 2003. MFR DID C/A #CT041003 FOR FIX, THIS FIX WAS ISSUED AND IMPLEMENTED DECEMBER 2004. THIS IS BEING REPORTED UNDER MALFUNCTION WHICH COULD HAVE RESULTED TO SERIOUS INJURY OR DEATH AS DEFINED IN 21 CFR PART 803.3 / 803.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOYER LIFT PT LIFTER FSA APEX HLTHCARE MFG INC C-HLA-2 *

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other