BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOYER LIFTER

    MDR report key: 746049 · Received August 7, 2006

    Report

    Report Number
    2182305-2006-00031
    Event Type
    Other
    Date Received
    August 7, 2006
    Date of Event
    July 9, 2006
    Report Date
    August 4, 2006
    Manufacturer
    APEX HEALTHCARE MFG INC
    Product Code
    FNG
    Removal / Correction Number
    Z-0904-06
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO MANUFACTURER, BY FACILITY, THAT WHILE USING HOYER LIFT TO TRANSFER A RESIDENT OUT OF HER BED, THE LIFT FAILED. PER FACILITY, THE BOLT UNDERNEATH THE HYD CHAMBER CAME OUT AND THE BOOM CAME DOWN ON AND HIT THE RESIDENT. RESIDENT FELL BACK ONTO HER BED. LIFT HIT HER RIGHT HAND, SMALL REDDEN AREA TO KNUCKLE AND HAD SWELLING. PER FACILITY, WHEN THE HOYER LIFT ARRIVED, THE MAINTENANCE MAN HAD LEFT FOR THE DAY. SO C.N.A. PUT THE LIFT TOGETHER AND ONCE THE LIFT WAS TOGETHER THEY USED SAID LIFT. THE NEXT DAY, THE MAINTENANCE MAN CHECKED THE LIFT OVER TO BE SURE IT WAS IN CORRECT WORKING ORDER AND IT WAS ALLOWED TO BE USED. MANUFACTURER SENT REPLACEMENT JACK OUT AND ISSUED RMA #681538 FOR RETURN AND EVALUATION. MFG DATE OF OCTOBER 2003. MANUFACTURER DID FOR FIX, THIS FIX WAS ISSUED AND IMPLEMENTED DECEMBER 2004.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOYER LIFTER PATIENT LIFTER FNG APEX HEALTHCARE MFG INC HML400 *

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other