BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PERFUSION SYSTEM 8000

    MDR report key: 1170744 · Received September 15, 2008

    Report

    Report Number
    1828100-2008-00432
    Event Type
    Malfunction
    Date Received
    September 15, 2008
    Date of Event
    August 20, 2008
    Report Date
    September 15, 2008
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K915183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IN PROGRESS, BUT NOT CONCLUDED.

    Description of Event or Problem · 1

    DURING PREVENTATIVE MAINTENANCE OF THE DEVICE, THE TECHNICIAN REPORTED THE LEVEL SYSTEM WOULD NOT POWER OFF OR RESET WITH THE POWER BUTTON ON THE SAFETY MONITOR. THE TECHNICIAN REPLACED THE LEVEL DETECTION BOARD. THERE WAS NO ADVERSE CONSEQUENCE TO A PT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO PERFUSION SYSTEM 8000 HEART LUNG CONSOLE DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 16404

    Patients

    Seq Age Sex Outcome Treatment
    1