BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C1000 (TOUCH) THERMAL CYCLER CHASSIS

    MDR report key: 5802101 · Received July 18, 2016

    Report

    Report Number
    MW5063473
    Event Type
    Malfunction
    Date Received
    July 18, 2016
    Date of Event
    June 8, 2016
    Report Date
    July 12, 2016
    Manufacturer
    BIO-RAD
    Product Code
    OUL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2016, (B)(6) STAFF REPORTS, HEARD POPPING COMING FROM THERMAL CYCLER. UNIT STARTED SPARKING AND SMOKING. SPARKS AND FLAMES WERE NEAR THE POWER SWITCH. UNIT SERIAL NUMBER (B)(4). UNIT RETURNED TO BIO-RAD FOR REPAIR. ACCORDING TO BIO-RAD THE MALFUNCTION THAT CAUSED THE SPARKS, POPPING NOISE AND FLAMES IS DUE TO A DEFECTIVE POWER SUPPLY. BIO-RAD DID NOT ISSUE A RECALL BECAUSE OF A LESS THAN (b)(4) FAILURE RATE, AND THOUGHT THAT ISSUE IS CONTAINED TO A POWER SUPPLY ENCLOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455634 C1000 (TOUCH) THERMAL CYCLER CHASSIS THERMAL CYCLER OUL BIO-RAD C1000

    Patients

    Seq Age Sex Outcome Treatment
    1