BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTIDEBRIDER POWER CONSOLE

    MDR report key: 10397478 · Received August 12, 2020

    Report

    Report Number
    1037007-2020-00033
    Event Type
    Malfunction
    Date Received
    August 12, 2020
    Report Date
    August 12, 2020
    Manufacturer
    GYRUS ACMI, INC
    Product Code
    GIE
    PMA / PMN Number
    K123429
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT YET BEEN RECEIVED FOR EVALUATION. THE CAUSE OF THE ISSUE CANNOT BE DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR USE, THE DEVICE EXHIBITED ERROR 12 ERROR MESSAGE. ACCORDING TO THE REPORTER, THE INTENDED PROCEDURE WAS COMPLETED BY SWITCHING TO ANOTHER SIMILAR DEVICE. TYPE OF PROCEDURE, SERIAL NUMBER OF THE DEVICE USED TO COMPLETE THE PROCEDURE WAS NOT PROVIDED. THERE WAS NO PATIENT HARM OR IMPACT REPORTED DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862548 MULTIDEBRIDER POWER CONSOLE OLYMPUS ENERGY POWER SYSTEM (EPS) GIE GYRUS ACMI, INC MDCONS100

    Patients

    Seq Age Sex Outcome Treatment
    1