BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    MDR report key: 1840726 · Received September 17, 2010

    Report

    Report Number
    1828100-2010-01646
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Date of Event
    June 4, 2010
    Report Date
    September 17, 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 REPAIR CENTER, THE USER REPORTED THE MONITOR FAILED TO POWER ON. THE SINGLE BOARD COMPUTER AND BATTERIES WERE REPLACED TO RESOLVE THE PROBLEM. THE MONITOR WAS ORIGINALLY RETURNED FOR FAILURE TO POWER ON. 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. 500AHCT

    Patients

    Seq Age Sex Outcome Treatment
    1