BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOLDEN COMFORTER

    MDR report key: 2820891 · Received October 3, 2012

    Report

    Report Number
    2523995-2012-00001
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Date of Event
    September 26, 2012
    Report Date
    September 28, 2012
    Manufacturer
    GOLDEN TECHNOLOGIES, INC.
    Product Code
    FNG
    PMA / PMN Number
    K880800
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT HAPPENED IN (B)(6). GOLDEN TECHNOLOGIES, INC. OFFERED THE THERASAGE ((B)(4)) FAR HEATING PAD AS AN OPTION ON CERTAIN MODELS OF THEIR CHAIRS. THE FAILURE IS IN THE FAR PAD AND NOT IN THE GOLDEN TECHNOLOGIES LIFT CHAIR. A SAFETY ALERT WAS ISSUED ON (B)(4) 2012 BY GOLDEN TECHNOLOGIES FOR THE FAR HEATING SYSTEM USED INSIDE SOME GOLDEN TECHNOLOGIES CHAIRS. GOLDEN HAS ASKED ALL CONSUMERS TO UNPLUG THE THERASAGE HEAT PAD AND WILL PERMANENTLY DISABLE THE FAR SYSTEM. ADDITIONALLY, GOLDEN HAS DISCONTINUED USE OF THE FAR PADS IN ANY AND ALL FUTURE PRODUCTS. THE SAFETY ALERT DOES NOT INCLUDE GOLDEN'S STANDARD HEAT AND MESSAGE SYSTEM.

    Description of Event or Problem · 1

    CUSTOMER WAS SITTING IN CHAIR AND TURNED ON THE OPTIONAL THERASAGE HEATING PAD. SHE HEARD A POP, GOT OFF THE CHAIR AND SAW SMOKE. THE CHAIR THEN CAUGHT ON FIRE. HUSBAND BEAT THE FLAMES OUT WITH HIS HANDS. NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GOLDEN COMFORTER LIFT CHAIR FNG GOLDEN TECHNOLOGIES, INC. PR501

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK