BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVATEMP C-400 SERIES

    MDR report key: 3672177 · Received March 5, 2014

    Report

    Report Number
    3672177
    Event Type
    Malfunction
    Date Received
    March 5, 2014
    Date of Event
    December 10, 2013
    Report Date
    March 5, 2014
    Manufacturer
    NOVAMEDUSA
    Product Code
    KRI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE IN AN OR, THE PATIENT'S TEMP READINGS WERE DRIFTING IN EXCESS OF 2.5 DEGREES. IT WAS FOUND TO BE A FAILURE OF THE TEMP PROBE. UPON OUR INVESTIGATION, WE FOUND THAT IT HAD HAPPENED AT LEAST FOUR TIMES PRIOR TO THIS DOCUMENTED EVENT WITH DIFFERENT ANESTHESIOLOGISTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131317 NOVATEMP C-400 SERIES ACCESSORY EQUIPMENT, CARDIOPULMONARY BYPASS, TEMPERATURE PRO KRI NOVAMEDUSA 9FR 131163101

    Patients

    Seq Age Sex Outcome Treatment
    1 * NOTHING THAT WOULD CONTRIBUTE TO EVENT.