BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S1000 THERMAL CYCLER CHASSIS

    MDR report key: 5802609 · Received July 18, 2016

    Report

    Report Number
    MW5063496
    Event Type
    Malfunction
    Date Received
    July 18, 2016
    Date of Event
    May 3, 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
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2016, BLOOD CENTER OF WISCONSIN LAB STAFF REPORTS, INSTRUMENT MADE A POPPING SOUND, BURNING SMELL THEN WENT DEAD. UNIT SERIAL NUMBER (B)(4). UNIT RETURNED TO BIO-RAD FOR REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455687 S1000 THERMAL CYCLER CHASSIS THERMAL CYCLER OUL BIO-RAD S1000

    Patients

    Seq Age Sex Outcome Treatment
    1