BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOYER LIFT

    MDR report key: 730356 · Received June 26, 2006

    Report

    Report Number
    2182305-2006-00022
    Event Type
    Other
    Date Received
    June 26, 2006
    Date of Event
    May 26, 2006
    Report Date
    June 12, 2006
    Manufacturer
    APEX HEALTHCARE MFG. INC
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO MFR BY JUDY HAYS PURCHASING AGENT IN BEHALF OF THE FACILITY, THE ELMS. PER JUDY THIS FACILITY HAD ANOTHER INCIDENT WHILE USING A LIFT. (1ST ONE WAS REPORTED ON 04/10/2006 NOTE MDR # 2182305-2006-0012). AT FIRST IT WAS THOUGHT TO BE THE SAME SITUATION AS THE EARLIER INCIDENT HOWEVER AFTER FURTHER DISCUSSIONS IT WAS DETERMINED THE SAME ASSEMBLY IS NEEDED BUT IT WAS EVIDENT FROM THE PICTURE SENT THAT IT WAS NOT A BOLT ISSUE BUT A PIECE PART WELD ISSUE. THE SMALL ROUND TUBE WHERE THE ADJUSTING LEVER HANDLE FITS INTO AND THAT IS ATTACHED ONTO THE BASE IS WHERE THE WELD FAILED. FACILITY DESCRIBED THIS INCIDENT AS THE LEGS WERE OPEN AND WHEN THEY CLOSED. NO INJURY TO THE RESIDENT IN THE LIFT, THE C.N.A. HAS COMPLAINED OF INJURY. UNK AS TO WHAT KIND OF INJURY OR WHETHER SHE WAS OFF OF WORK BECAUSE OF THIS ALLEGED INJURY. MFR ISSUED RMA #673466 TO GET ASSEMBLY BACK FOR EVALUATION AND REPLACED ASSEMBLY IN QUESTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOYER LIFT PATIENT LIFTER FSA APEX HEALTHCARE MFG. INC HPL402 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other