BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO STERNAL SAW II

    MDR report key: 1981591 · Received January 31, 2011

    Report

    Report Number
    1828100-2011-00065
    Event Type
    Malfunction
    Date Received
    January 31, 2011
    Date of Event
    January 6, 2011
    Report Date
    January 31, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP
    Product Code
    GFA
    PMA / PMN Number
    K935391
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THE FOOT PEDAL INTERMITTENTLY WORKED. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WERE NO ADVERSE CONSEQUENCES TO A PT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO STERNAL SAW II STERUM SAW FOOTSWITCH GFA TERUMO CARDIOVASCULAR SYSTEMS CORP 15675

    Patients

    Seq Age Sex Outcome Treatment
    1