BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 1082613 · Received July 23, 2008

    Report

    Report Number
    1828100-2008-00358
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    July 3, 2008
    Report Date
    July 23, 2008
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IN PROGRESS, BUT NOT CONCLUDED.

    Description of Event or Problem · 1

    DURING AN EXHIBITION OF THE DEVICE, THE TOUCH PANEL OF THE CENTRAL CONTROL MONITOR OF THE HEART LUNG CONSOLE DID NOT FUNCTION AS EXPECTED. CONTROL OF PUMPS AND SAFETY SENSORS REMAINED AVAILABLE THROUGH REDUNDANT LOCAL CONTROLS. THERE WAS NO REPORTED ADVERSE CONSEQUENCE TO A PATIENT AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1