BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOLDEN PR 751TY REGAL

    MDR report key: 1025888 · Received April 5, 2008

    Report

    Report Number
    2523955-2008-00001
    Event Type
    Malfunction
    Date Received
    April 5, 2008
    Date of Event
    March 13, 2008
    Report Date
    April 1, 2008
    Manufacturer
    GOLDEN TECHNOLOGIES, INC.
    Product Code
    INO
    PMA / PMN Number
    K880800
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A GOLDEN TECHNOLOGIES REPRESENTATIVE, VISITED THE SCENE OF THE FIRE TO DETERMINE IF THE CHAIR WAS THE CAUSE OF FIRE. IT IS MFR'S PROFESSIONAL JUDGEMENT THAT IT IS HIGHLY UNLIKELY THAT THE LIFT CHAIR COULD HAVE CAUSED THE FIRE SINCE IT STILL OPERATED DURING THE FIRE. IF THE CHAIR WIRING HAD STARTED THE FIRE THE CHAIR WOULD BE RENDERED INOPERABLE, AND THE FIRE WOULD HAVE MOST LIKELY STARTED ON THE RIGHT SIDE SEATED WHERE THE WIRING IS. LASTLY THE FIRE BURNED DOWNWARD UNDER THE CHAIR THROUGH THE SUBFLOOR AROUND THE CHAIR. IF THE CHAIR CAUGHT FIRE, IT WOULD HAVE BURNED UPWARD, NOT DOWNWARD.

    Description of Event or Problem · 1

    PATIENT STATES THAT SHE WAS ASLEEP IN THE LIFT CHAIR AND AWOKE TO A SENSATION OF HEAT AND DISCOVERED THE CHAIR WAS ON FIRE. THE FIRE WAS ON THE LEFT HAND SIDE SEATED OF THE CHAIR WHERE THERE WAS NO ELECTRICAL WIRING THAT WAS PART OF THE CHAIR. AT THE TIME OF THE FIRE THE CHAIR WAS STILL OPERABLE, AND THE PATIENT WAS ABLE TO UTILIZE THE ELECTRICAL LIFT MECHANISM IN THE CHAIR TO TRANSFER TO THEIR ELECTRIC SCOOTER AND EXIT THE HOUSE WITHOUT ANY SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GOLDEN PR 751TY REGAL CHAIR, POSITIONING, ELECTRIC INO GOLDEN TECHNOLOGIES, INC. PR 751TY REGAL

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Life Threatening