BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    MDR report key: 1961084 · Received January 11, 2011

    Report

    Report Number
    1828100-2010-02860
    Event Type
    Malfunction
    Date Received
    January 11, 2011
    Date of Event
    December 17, 2010
    Report Date
    January 11, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DRY
    PMA / PMN Number
    K972962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    DURING PREVENTATIVE MAINTENANCE OF THE DEVICE, THE USER OBSERVED A HEMATOCRIT SATURATION MODULE COLOR CHIP FAILURE ERROR MESSAGE. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED. SINCE THE EVENT OCCURRED DURING PREVENTATIVE MAINTENANCE OF THE DEVICE, THERE WAS NO PATIENT INVOLVEMENT DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO CDI 500 BLOOD PARAMETER MONITOR ONLINE BLOOD GAS MONITOR DRY TERUMO CARDIOVASCULAR SYSTEMS CORP. 500AVHCT

    Patients

    Seq Age Sex Outcome Treatment
    1