BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PERFUSION SYSTEM 8000

    MDR report key: 2040560 · Received March 18, 2011

    Report

    Report Number
    1828100-2011-00629
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 21, 2011
    Report Date
    March 18, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    JOR
    PMA / PMN Number
    K915183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING USE OF THE DEVICE FOR A NON-CLINICAL ACTIVITY, THE USER OBSERVED A RED FLASHING LIGHT ON THE BATTERY. SINCE THE EVENT OCCURRED DURING A NON-CLINICAL ACTIVITY, THERE WAS NO PATIENT INVOLVEMENT DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO PERFUSION SYSTEM 8000 PUMP JOR TERUMO CARDIOVASCULAR SYSTEMS CORP. 16401

    Patients

    Seq Age Sex Outcome Treatment
    1