BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PERFUSION SYSTEM 8000

    MDR report key: 2380909 · Received November 10, 2011

    Report

    Report Number
    1828100-2011-03554
    Event Type
    Malfunction
    Date Received
    November 10, 2011
    Date of Event
    October 14, 2011
    Report Date
    November 10, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    JOR
    PMA / PMN Number
    K915183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING USE OF THE DEVICE FOR A NON-CLINICAL ACTIVITY, THE FIELD SERVICE REPRESENTATIVE REPORTED THAT THERE WAS AN OPEN GROUND WIRE EXPOSED ON THE POWER CORD. SINCE THE EVENT OCCURRED DURING PREVENTATIVE MAINTENANCE, THERE WAS NO PATIENT 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 SYSTEMS CORP. 16401

    Patients

    Seq Age Sex Outcome Treatment
    1