BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    MDR report key: 1791558 · Received August 6, 2010

    Report

    Report Number
    1828100-2010-01091
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Date of Event
    July 22, 2010
    Report Date
    August 6, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP
    Product Code
    DRY
    PMA / PMN Number
    K972962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    DURING USE OF THE DEVICE FOR A NON-CLINICAL ACTIVITY, THE USER REPORTED THE SENSOR PORTION OF THE PROBE HAD SEPARATED FROM THE HOUSING. THE PROBE WOULD NOT HOOK INTO THE CALIBRATOR OR ONTO THE CUVETTE. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED. SINCE THIS EVENT OCCURRED DURING A NON-CLINICAL ACTIVITY, THERE WAS NO PT INVOLVEMENT DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO CDI 500 BLOOD PARAMETER MONITOR ON LINE BLOOD GAS MONITOR DRY TERUMO CARDIOVASCULAR SYSTEMS CORP 500AHCT

    Patients

    Seq Age Sex Outcome Treatment
    1