BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO STERNAL SAW

    MDR report key: 2182636 · Received July 5, 2011

    Report

    Report Number
    1828100-2011-01886
    Event Type
    Malfunction
    Date Received
    July 5, 2011
    Date of Event
    June 2, 2011
    Report Date
    July 5, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    GFA
    PMA / PMN Number
    K935391
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THAT THE MOTOR DID NOT WORK. THE COVER WAS REMOVED AND THE MOUNT HOOKS WERE BROKEN. THE UNIT WAS DROPPED A COUPLE OF TIMES. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. 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 POWER UNIT (MOTOR) 115V GFA TERUMO CARDIOVASCULAR SYSTEMS CORP. 15670

    Patients

    Seq Age Sex Outcome Treatment
    1