BEUDAMED
    FDA Adverse Event Other Summary report: N

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    MDR report key: 1734025 · Received June 21, 2010

    Report

    Report Number
    1828100-2010-00680
    Event Type
    Other
    Date Received
    June 21, 2010
    Date of Event
    June 3, 2010
    Report Date
    June 21, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DRY
    PMA / PMN Number
    K972962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING ROUTINE TESTING OF THE DEVICE AT THE SERVICE CENTER, THE USER REPORTED THAT THE UNIT CAME IN FOR A COLOR CHIP FAILURE. THE USER REPORTED THE HSAT MODULE WAS REPLACED AND UPON FURTHER TESTING, A PROBE ON THE DEVICE FAILED THE MANUFACTURER SELF-TEST. SINCE THIS EVENT OCCURRED DURING ROUTINE TESTING, THERE WAS NO PT INVOLVEMENT.

    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