BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 1942112 · Received November 11, 2010

    Report

    Report Number
    1828100-2010-02054
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    October 18, 2010
    Report Date
    November 11, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    DURING FIELD SERVICE INSTALLATION OF THE DEVICE, THE USER REPORTED THE OXYGEN SENSOR CARTRIDGE DID NOT FUNCTION AS EXPECTED. THE USER REPORTED THE FIO2 VALUE WOULD NOT GO BELOW 27.2. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED. SINCE THE EVENT OCCURRED DURING FIELD SERVICE INSTALLATION OF THE DEVICE, THERE WAS NO PATIENT INVOLVEMENT DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO ADVANCED PERFUSION SYSTEM 1 OXYGEN SENSOR CARTRIDGE DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 801074

    Patients

    Seq Age Sex Outcome Treatment
    1