BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 1181050 · Received September 29, 2008

    Report

    Report Number
    1828100-2008-00456
    Event Type
    Malfunction
    Date Received
    September 29, 2008
    Date of Event
    September 4, 2008
    Report Date
    September 29, 2008
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    DURING INSTALLATION OF THE POWER SUPPLY, THE FIELD SERVICE REPRESENTATIVE OBSERVED ONE OF THE POWER SUPPLIES FAILED AT START UP. THE REPRESENTATIVE EMPLOYED AN ALTERNATIVE DEVICE. THE DEVICE WAS INSTALLED AND TESTED TO WORK TO SPECIFICATION. THERE WAS NO ADVERSE CONSEQUENCE TO A PT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO ADVANCED PERFUSION SYSTEM 1 HEART LUNG CONSOLE DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 801763

    Patients

    Seq Age Sex Outcome Treatment
    1