BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PERFUSION SYSTEM 8000

    MDR report key: 2211855 · Received August 10, 2011

    Report

    Report Number
    1828100-2011-02387
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    July 15, 2011
    Report Date
    August 10, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    JOR
    PMA / PMN Number
    K915183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING PREVENTATIVE MAINTENANCE OF THE DEVICE. THE FIELD SERVICE REP REPORTED THAT THE LENS COVER WAS MISSING. 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 BATTERY MODULE JOR TERUMO CARDIOVASCULAR SYSTEMS CORP. 16422

    Patients

    Seq Age Sex Outcome Treatment
    1