BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO STERNAL SAW II

    MDR report key: 3040318 · Received April 3, 2013

    Report

    Report Number
    1828100-2013-00321
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 14, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORP.
    Product Code
    GFA
    PMA / PMN Number
    K935391
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE POWER UNIT ON THE STERNAL SAW HAD POWER, BUT THE MOTOR WAS NOT TURNING. THE USER FACILITY'S BIOMEDICAL ENGINEER (BIOMED) HOOKED THE MOTOR UP TO A FOOT PEDAL TO TEST AND IT WOULD NOT TURN OVER. NO OTHER DETAILS REGARDING THE NATURE OF THIS EVENT WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136505 TERUMO STERNAL SAW II GFA TERUMO CARDIOVASCULAR SYSTEM CORP. 15670

    Patients

    Seq Age Sex Outcome Treatment
    1