BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    MDR report key: 1842150 · Received August 31, 2010

    Report

    Report Number
    1828100-2010-01235
    Event Type
    Malfunction
    Date Received
    August 31, 2010
    Date of Event
    June 11, 2010
    Report Date
    August 31, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DRY
    PMA / PMN Number
    K972962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    UPON RECEIPT OF THE DEVICE, THE USER OBSERVED A "F050" FAILURE MESSAGE. OUR FOREIGN CONSIGNEE TESTED THE MONITOR AND PERFORMED A SUCCESSFUL CALIBRATION. AS A RESULT, THE "F050" FAILURE MESSAGE DISAPPEARED. OUR FOREIGN CONSIGNEE REPORTED THE DEVICE WAS RETURNED TO THE CUSTOMER. SINCE THE EVENT OCCURRED UPON RECEIPT 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 ON LINE BLOOD GAS MONITOR DRY TERUMO CARDIOVASCULAR SYSTEMS CORP. 500AHCT

    Patients

    Seq Age Sex Outcome Treatment
    1