BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOYER LIFT

    MDR report key: 858107 · Received May 30, 2007

    Report

    Report Number
    2182305-2007-00018
    Event Type
    Other
    Date Received
    May 30, 2007
    Date of Event
    May 16, 2007
    Report Date
    May 18, 2007
    Manufacturer
    APEX HEALTHCARE MFG INC.
    Product Code
    FNG
    Removal / Correction Number
    Z-0904-06
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO MFR, THE FACILITY WAS TRANSFERRING A RESIDENT OUT OF BED, HE WAS STILL OVER THE BED, WHEN THE LIFT FAILED. THE THREADED STUD THAT GOES INTO THE BOTTOM OF THE JACK FELL OUT. RESIDENT WAS NOT INJURED WHEN HE FELL BACK ON TO BED. MFR SENT REPLACEMENT JACK OUT AND ISSUED RMA #741246 FOR RETURN AND EVAL OF JACK IN QUESTION. MFR DATE OF JUNE 2003. MFR DID C/A #CT041003 FOR FIX, THIS FIX WAS ISSUED AND IMPLEMENTED 2004. MFR RECEIVED CONFIRMATION THAT OCECLO INC. RECEIVED THE URGENT MEDICAL DEVICE CORRECTION NOTICE AND SENT BACK GREEN CARD. HOWEVER, ET CARE INC. REFUSED THE MAILING ON 9/19/06, 9/28/06, AND 10/5/06 PER THE UNITED STATES POSTAL SERVICE AND WAS RETURNED TO MFG AS REFUSED BY ADDRESSEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOYER LIFT PATIENT LIFTER FNG APEX HEALTHCARE MFG INC. C-HLA-2

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Other