BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 1834563 · Received September 9, 2010

    Report

    Report Number
    1828100-2010-01391
    Event Type
    Malfunction
    Date Received
    September 9, 2010
    Date of Event
    August 18, 2010
    Report Date
    September 9, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    UPON RECEIPT OF THE DEVICE, THE SALES REP REPORTED, THE CENTRAL CONTROL MONITOR SCREEN UNEXPECTEDLY FROZE AND WOULD NOT BOOT UP AS EXPECTED. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED. SINCE THIS EVENT OCCURRED UPON RECEIPT OF THE DEVICE, THERE WAS NO PT INVOLVEMENT DURING THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1