BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PERFUSION SYSTEM 8000

    MDR report key: 2191055 · Received July 19, 2011

    Report

    Report Number
    1828100-2011-02373
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    June 26, 2011
    Report Date
    July 19, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    JOR
    PMA / PMN Number
    K915183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE USER REPORTED THAT THE ARTERIAL MONITOR TEMP "A" DISPLAY WAS BLANK. THE USER WAS ABLE TO USE THE "B" TEMP DISPLAY FOR THE PROCEDURE AND REPORTED THAT THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO PERFUSION SYSTEM 8000 ARTERIAL MONITOR JOR TERUMO CARDIOVASCULAR SYSTEMS CORP. 16413

    Patients

    Seq Age Sex Outcome Treatment
    1