BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PERFUSION SYSTEM 8000

    MDR report key: 2802558 · Received October 19, 2012

    Report

    Report Number
    1828100-2012-01410
    Event Type
    Malfunction
    Date Received
    October 19, 2012
    Date of Event
    September 13, 2012
    Report Date
    September 13, 2012
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORP
    Product Code
    DTQ
    PMA / PMN Number
    K915183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED THIS SYSTEM IS USED FOR TRAINING PURPOSES ONLY AND THEY DECLINED REPAIRS AT THIS TIME.

    Description of Event or Problem · 1

    THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT DURING PREVENTATIVE MAINTENANCE (PM) OF THE DEVICE, THE BATTERY UNIT HAD ISSUES AND DOES NOT SUPPORT THE SYSTEM WHEN ALTERNATING CURRENT (A/C) VOLTAGE WAS REMOVED. SINCE THE EVENT OCCURRED DURING PREVENTATIVE MAINTENANCE, THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO PERFUSION SYSTEM 8000 DTQ TERUMO CARDIOVASCULAR SYSTEM CORP 16422

    Patients

    Seq Age Sex Outcome Treatment
    1