BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CDI 5000 BLOOD PARAMETER MONITOR

    MDR report key: 2241019 · Received August 17, 2011

    Report

    Report Number
    1828100-2011-02472
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    July 15, 2011
    Report Date
    August 17, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORP.
    Product Code
    DRY
    PMA / PMN Number
    K972962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE USER REPORTED THAT THE HOUSING ON THE HEMATOCRIT SATURATION PROBE WAS SPLIT APART AND HAD TO BE TAPED. NO OTHER DETAILS REGARDING THE NATURE OF THIS EVENT WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO CDI 5000 BLOOD PARAMETER MONITOR ON LINE BLOOD GAS MONITOR DRY TERUMO CARDIOVASCULAR SYSTEM CORP. 500AHCT

    Patients

    Seq Age Sex Outcome Treatment
    1