BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GOLDEN LIFT CHAIR WITH FIR HEAT

    MDR report key: 2835000 · Received October 1, 2012

    Report

    Report Number
    3005893178-2012-00001
    Event Type
    Injury
    Date Received
    October 1, 2012
    Report Date
    October 1, 2012
    Manufacturer
    GOLDEN TECHNOLOGIES
    Product Code
    INO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL: UC550.

    Description of Event or Problem · 1

    GOLDEN TECHNOLOGIES, A US-BASED OEM MFR, ("GOLDEN") PRODUCES ELECTRIC POSITIONING (OR LIFT) CHAIRS AS CLASSIFIED UNDER CFR 890.3110. FOR SEVERAL YEARS, GOLDEN HAS CONTRACTED WITH THERASAGE, (B)(4), FOR THE PURCHASE OF AN INFRARED INTO ITS CHAIRS TO PROVIDE USER-CONTROLLED HEAT TO THE USER. THERASAGE SERVED AS THE IMPORTER/CONTRACT MFR OF THIS SUBASSEMBLY COMPONENT. GOLDEN PROVIDED THE SPECIFICATIONS FOR THIS COMPONENT AND, AFTER DELIVERY OF THE COMPONENT FROM THERASAGE, HAD THE SOLE CONTROL AND RESPONSIBILITY FOR ASSEMBLY, INTEGRATION, DELIVERY, AND EXPLANATION OF USE. ON (B)(6) 2012, GOLDEN INFORMED THERASAGE OF SEVERAL ISOLATED, ADVERSE EVENTS RELATED TO ITS CHAIR, ISOLATED EVENTS IN WHICH POTENTIAL PROPERTY DAMAGE MAY HAVE OCCURRED. THERASAGE REQUESTED ANY FORENSIC REPORTED TO THESE INCIDENTS BE FORWARDED FOR REVIEW BY THERASAGE'S FACTORY AND ORIGINAL MFR. NO SUCH REPORTS WERE EVER TRANSMITTED; HOWEVER, GOLDEN VERBALLY CONFIRMED TO THERASAGE THAT THE SUSPECTED EVENTS APPEARED TO HAVE BEEN CAUSED BY EITHER USER ERROR OR A MALFUNCTION/EVENT CAUSED BY POOR DESIGN OR FUNCTION SPECIFICATIONS ASSOCIATED WITH THE CHAIR ITSELF. THERASAGE HAS NOT BEEN INFORMED OF ANY SPECIFICS OF EVENTS; RATHER, GOLDEN'S MANAGER OF QUALITY ASSURANCE HAS MENTIONED SEVERAL INSTANCES OF CHAIR MALFUNCTIONS, PROPERTY DAMAGE, AND POTENTIAL USER INJURY. THERASAGE, WHICH ONLY SERVED AS THE CONTRACT MFR/IMPORTER OF A SUBASSEMBLY COMPONENTS FOR GOLDEN TECHNOLOGIES IS FILING THIS REPORT WITH THE INFO IT DOES HAVE, ALTHOUGH THAT INFO IS INCOMPLETE, PRIMARILY THIRD PARTY, AND UNCORROBORATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GOLDEN LIFT CHAIR WITH FIR HEAT INO GOLDEN TECHNOLOGIES PR501

    Patients

    Seq Age Sex Outcome Treatment
    1