BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 3140008 · Received May 28, 2013

    Report

    Report Number
    1828100-2013-00532
    Event Type
    Malfunction
    Date Received
    May 28, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 6, 2013
    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 IS IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SETUP PRIOR TO ELECTRO-MAGNETIC COMPATIBILITY (EMC) TESTING, THE CENTRAL CONTROL MONITOR (CCM) BOOTED UP AND SHOWED A RED WINDOW STATING TO CALL SERVICE FOR REPAIRS. THIS WAS CATEGORIZED AS AN "OUT OF BOX" FAILURE. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233075 TERUMO ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 816300

    Patients

    Seq Age Sex Outcome Treatment
    1