BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CENTRIFUGAL SYSTEM

    MDR report key: 1182036 · Received September 22, 2008

    Report

    Report Number
    1828100-2008-00440
    Event Type
    Malfunction
    Date Received
    September 22, 2008
    Date of Event
    August 28, 2008
    Report Date
    September 22, 2008
    Manufacturer
    TERUMO CARDIOVASCUALR SYSTEMS CORP
    Product Code
    DTQ
    PMA / PMN Number
    K902198
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    DURING PREVENTATIVE MAINTENANCE OF THE DEVICE, THE TECHNICIAN OBSERVED THE BATTERIES WERE DEAD. THE BATTERIES WERE REPLACED ONE YEAR AGO SUGGESTING A PREMATURE FAILURE. THERE WAS NO ADVERSE CONSEQUENCE TO A PATIENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO CENTRIFUGAL SYSTEM CENTRIFUGAL PUMP BATTERY MODULE DTQ TERUMO CARDIOVASCUALR SYSTEMS CORP 9490

    Patients

    Seq Age Sex Outcome Treatment
    1