BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO STERNAL SAW II

    MDR report key: 2030822 · Received March 4, 2011

    Report

    Report Number
    1828100-2011-00469
    Event Type
    Malfunction
    Date Received
    March 4, 2011
    Date of Event
    February 8, 2011
    Report Date
    March 4, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    GFA
    PMA / PMN Number
    K935391
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING PREVENTATIVE MAINTENANCE OF THE DEVICE, THE BIOMED REPORTED THAT THE POWER CORD ON THE FOOT SWITCH HAD SOME NICKS. SINCE THE EVENT OCCURRED DURING PREVENTATIVE MAINTENANCE OF THE DEVICE, THERE WAS NO PT INVOLVEMENT DURING THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1