BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CDI 100 MONITOR

    MDR report key: 1913427 · Received November 12, 2010

    Report

    Report Number
    1828100-2010-02058
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    October 19, 2010
    Report Date
    November 12, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP
    Product Code
    DTY
    PMA / PMN Number
    K902654
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    DURING ROUTINE TESTING OF THE DEVICE AT THE SERVICE CENTER, THE SERVICE TECHNICIAN REPORTED THE BATTERY FAILED TO HOLD A CHARGE. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED. THE MONITOR WAS ORIGINALLY RETURNED FOR A CALIBRATION FAILURE. SINCE THE EVENT OCCURRED AT THE SERVICE CENTER, THERE WAS NO PT INVOLVEMENT DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO CDI 100 MONITOR MONITOR DTY TERUMO CARDIOVASCULAR SYSTEMS CORP 100

    Patients

    Seq Age Sex Outcome Treatment
    1