BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PERFUSION SYSTEM 8000

    MDR report key: 2246237 · Received August 19, 2011

    Report

    Report Number
    1828100-2011-02475
    Event Type
    Malfunction
    Date Received
    August 19, 2011
    Date of Event
    July 26, 2011
    Report Date
    August 19, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORP
    Product Code
    JOR
    PMA / PMN Number
    K915183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    DURING ROUTINE PREVENTATIVE MAINTENANCE OF THE DEVICE, THE FIELD SERVICE ASSOCIATE REPORTED THAT THE AC CORD IN THE BASE OF THE MACHINE EXHIBITED THREE EXPOSED WIRES. THE INSULATION WAS OFF OF THE CORD. SINCE THE EVENT OCCURRED DURING PREVENTATIVE MAINTENANCE, THERE WAS NO PT INVOLVEMENT DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO PERFUSION SYSTEM 8000 HEART LUNG CONSOLE JOR TERUMO CARDIOVASCULAR SYSTEM CORP 16401

    Patients

    Seq Age Sex Outcome Treatment
    1