BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLARGEN 2100S CONSOLE

    MDR report key: 4931189 · Received July 22, 2015

    Report

    Report Number
    1063481-2015-00124
    Event Type
    Malfunction
    Date Received
    July 22, 2015
    Date of Event
    July 16, 2015
    Report Date
    July 17, 2015
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MNO
    PMA / PMN Number
    P970029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    ACCORDING TO THE NOTIFICATION RECEIVED BY FIELD ASSURANCE , THE LASER FOOT PEDAL WAS NOT RECOGNIZED BY LASER. THERE WAS NO INJURY TO THE PATIENT. THE PROCEDURE WAS COMPLETED BY HOLDING THE WIRE INTO THE FOOT PEDAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477891 SOLARGEN 2100S CONSOLE TRANSMYOCARDIAL REVASCULARIZATION LASER CONSOLE MNO CRYOLIFE, INC. SG-2100S VFC02

    Patients

    Seq Age Sex Outcome Treatment
    1 Other