BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PERFUSION SYSTEM 8000

    MDR report key: 4172362 · Received October 9, 2014

    Report

    Report Number
    1828100-2014-00858
    Event Type
    Malfunction
    Date Received
    October 9, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 18, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K915183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL IS IN PROGRESS, BUT NOT YET CONCLUDED. THE FSR REPLACED LIGHT EMITTING DIODE (LED) IN BATTERY UNIT CHARGE INDICATOR AND BATTERIES. THE FSR PERFORMED PREVENTIVE MAINTENANCE (PM) AND RELEASE TESTING. THE SYSTEM PERFORMED TO MANUFACTURER'S SPECIFICATIONS AND WAS RETURNED TO CLINICAL USE. THE SUSPECT PART WAS RETURNED TO THE MANUFACTURER FOR FURTHER EVAL.

    Description of Event or Problem · 1

    THE FIELD SVC REP (FSR) REPORTED THAT DURING PREVENTATIVE MAINTENANCE (PM) OF THE DEVICE, THE CHARGE INDICATOR WAS NOT ILLUMINATING. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636805 TERUMO PERFUSION SYSTEM 8000 8K DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 16422

    Patients

    Seq Age Sex Outcome Treatment
    1