BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 2102520 · Received May 20, 2011

    Report

    Report Number
    1828100-2011-01403
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    April 18, 2011
    Report Date
    May 20, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING INSTALLATION OF THE DEVICE, THE USER OBSERVED THAT ONE PIXEL ON THE CENTRAL CONTROL MONITOR WAS NOT RESPONDING WHEN RUNNING. SINCE THE EVENT OCCURRED DURING INSTALLATION, THERE WAS NO PATIENT INVOLVEMENT DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO ADVANCED PERFUSION SYSTEM 1 CENTRAL CONTROL MONITOR DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 816300

    Patients

    Seq Age Sex Outcome Treatment
    1