BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CERTRIFUGAL SYSTEM

    MDR report key: 2100144 · Received May 16, 2011

    Report

    Report Number
    1828100-2011-01390
    Event Type
    Malfunction
    Date Received
    May 16, 2011
    Date of Event
    April 22, 2011
    Report Date
    May 16, 2011
    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 FIELD SVC REP REPORTED THAT THE DRIVE MOTOR POWER CORD HAD A TEAR IN THE SHEATHING EXPOSING WIRES. SINCE THE EVENT OCCURRED DURING PREVENTATIVE MAINTENANCE, THERE WAS NO PT INVOLVEMENT DURING THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1