BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CENTRIFUGAL SYSTEM

    MDR report key: 3030839 · Received March 28, 2013

    Report

    Report Number
    1828100-2013-00300
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 8, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORP
    Product Code
    DWA
    PMA / PMN Number
    K950739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IS IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    THE SERVICE REPAIR TECHNICIAN (SRT) REPORTED THAT DURING ROUTINE TESTING OF THE DEVICE AT THE SERVICE CENTER, THE CENTRIFUGAL CONSOLE HAD A LOSS OF REVOLUTIONS PER MINUTE (RPM'S) ON THE MOTOR CONTROL. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128239 TERUMO CENTRIFUGAL SYSTEM DWA TERUMO CARDIOVASCULAR SYSTEM CORP 6379

    Patients

    Seq Age Sex Outcome Treatment
    1