BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATRICURE CRYOICE

    MDR report key: 10520772 · Received September 11, 2020

    Report

    Report Number
    10520772
    Event Type
    Malfunction
    Date Received
    September 11, 2020
    Date of Event
    August 19, 2020
    Report Date
    August 19, 2020
    Manufacturer
    ATRICURE, INC.
    Product Code
    GXH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WE WERE USING ATRICURE CRYO ICE AND EVERYTHING WAS PLUGGED IN CORRECTLY. MACHINE WOULD NOT GO BELOW -20 DEGREES. WE CHECKED MACHINE AND EVERYTHING WAS PLUGGED IN AND TURNED ON CORRECTLY. MANUFACTURER RESPONSE FOR ATRICURE CRYO ICE, ATRICURE CRYO ICE (PER SITE REPORTER): WE CALLED VENDOR WHO STATED TO TURN OFF MACHINE. MACHINE WAS TURNED OFF AND TURNED BACK ON, STILL WOULD NOT FREEZE TO CORRECT TEMPERATURE. WE GOT A NEW MACHINE AND AGAIN WOULD NOT FREEZE TO CORRECT TEMPERATURE. WE GOT A NEW HAND PIECE AND IMMEDIATELY THAT HANDPIECE WORKED CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    987137 ATRICURE CRYOICE DEVICE, SURGICAL, CRYOGENIC GXH ATRICURE, INC. 98905

    Patients

    Seq Age Sex Outcome Treatment
    1 28470 DA