BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    MDR report key: 1931867 · Received November 30, 2010

    Report

    Report Number
    1828100-2010-02330
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 30, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DRY
    PMA / PMN Number
    K972962
    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 ARTERIAL MODULE STANDARD REFERENCE SENSOR INITIALIZATION TEST FAILED ON THE BLOOD PARAMETER MONITOR. SINCE THE EVENT OCCURRED AT THE SERVICE CENTER, 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. 500AVHCT

    Patients

    Seq Age Sex Outcome Treatment
    1