BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THROMBELASTROGRAPH COAGULATION ANALYZER - TEG

    MDR report key: 1872745 · Received September 30, 2010

    Report

    Report Number
    2429444-2010-00001
    Event Type
    Malfunction
    Date Received
    September 30, 2010
    Date of Event
    February 23, 2010
    Report Date
    September 29, 2010
    Manufacturer
    HAEMOSCOPE
    Product Code
    JPA
    PMA / PMN Number
    K002177
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS CONDUCTED AND IT WAS DETERMINED THAT THE POWER SUPPLY FAILED; THE ROOT CAUSE IS STILL UNDER INVESTIGATION. INITIALLY IT WAS DETERMINED THAT THIS EVENT WAS NOT REPORTABLE. DURING A RECENT FDA INSPECTION, FDA PROVIDED GUIDANCE THAT THIS EVENT SHOULD HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    POWER SUPPLY FAILED AND THE CUSTOMER REPORTED SMOKE FROM UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THROMBELASTROGRAPH COAGULATION ANALYZER - TEG THROMBELASTROGRAPH INSTRUMENT JPA HAEMOSCOPE TEG 5000

    Patients

    Seq Age Sex Outcome Treatment
    1