BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CENTRIFUGAL SYSTEM

    MDR report key: 1761029 · Received July 14, 2010

    Report

    Report Number
    1828100-2010-00826
    Event Type
    Malfunction
    Date Received
    July 14, 2010
    Date of Event
    June 24, 2010
    Report Date
    July 14, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP
    Product Code
    DWA
    PMA / PMN Number
    K950739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING PREVENTATIVE MAINTENANCE OF THE DEVICE, THE SERVICE TECHNICIAN REPORTED THAT THE LED ON THE BATTERY BACKUP WAS NOT ILLUMINATED, SUGGESTING THAT BACKUP BATTERY POWER MAY NOT BE AVAILABLE. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED. SINCE THE EVENT OCCURRED DURING PREVENTATIVE MAINTENANCE OF THE DEVICE, THERE WAS NO PT INVOLVEMENT DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO CENTRIFUGAL SYSTEM CENTRIFUGAL CONTROL MODULE DWA TERUMO CARDIOVASCULAR SYSTEMS CORP 6379

    Patients

    Seq Age Sex Outcome Treatment
    1