BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 2030857 · Received March 4, 2011

    Report

    Report Number
    1828100-2011-00585
    Event Type
    Malfunction
    Date Received
    March 4, 2011
    Date of Event
    February 9, 2011
    Report Date
    March 4, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING PREVENTATIVE MAINTENANCE OF THE DEVICE, THE USER REPORTED THAT THE HEART LUNG CONSOLE FAILED TO OPERATE ON BATTERY POWER. THE CONSOLE WOULD ONLY OPERATE WHEN PLUGGED INTO AN AC POWER SOURCE. SINCE THE EVENT OCCURRED DURING PREVENTATIVE MAINTENANCE 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 HEART LUNG CONSOLE DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 801764

    Patients

    Seq Age Sex Outcome Treatment
    1