BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFREEZE CRYOSPRAY SYSTEM

    MDR report key: 4279335 · Received November 19, 2014

    Report

    Report Number
    3004534508-2014-00004
    Event Type
    Malfunction
    Date Received
    November 19, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 19, 2014
    Manufacturer
    CSA MEDICAL INC
    Product Code
    GEH
    PMA / PMN Number
    K133258
    Removal / Correction Number
    9062377-11/10/14-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE TRUFREEZE CRYOTHERAPY SYSTEM PROVIDES A TIMER FOR THE USER TO TIME CRYOSPRAY TREATMENTS. THE TIMER DOES NOT START OR STOP CRYOSPRAYS. THE TIMER IS DISPLAYED ON THE PANEL PC'S TIMER PANEL IN MINUTES: SECONDS (0:00) FORMAT ALONG WITH A TIMER PROGRESS BAR. AUDIBLE TONES ARE GENERATED IN CONJUNCTION WITH THE PROGRESS BAR. THE TONES ARE GENERATED AT FIVE-SECOND INTERVALS AND AT EACH SECOND OF THE FINAL FIVE SECONDS APPROACHING THE TARGET SET TIME WHEN THE CRYOGEN PEDAL IS ENGAGED. IN ADDITION, USERS ARE TRAINED TO HAVE A NURSE OR TECH NOTIFY THE TREATING PHYSICIAN WHEN THE SPRAY TIME HAS BEEN COMPLETED. A LOSS OF THE AUDIBLE TONES HAS BEEN REPORTED ON SYSTEMS CONFIGURED WITH THE ADVANTECH POC-127 PANEL PC ON LIMITED OCCASIONS WHEN THERE HAS BEEN NO MANUAL INPUT INTO THE PANEL PC FOR EXTENDED PERIODS OF TIME (>10 MINUTES). THE TIMER DISPLAY FUNCTIONS CONTINUE TO OPERATE AS INTENDED. THERE HAVE BEEN NO OTHER ASSOCIATED ADVERSE EVENTS RELATED TO THIS ISSUE. HOWEVER, THERE IS THE POSSIBILITY THAT MORE CRYOGEN COULD BE DELIVERED THAN EXPECTED BY THE USER IF THEY RELY SOLELY ON THE AUDIBLE TONES. IN A PASSIVE VENTING PROCEDURE, THIS POTENTIAL EXCESS CRYOGEN DELIVERY COULD INDUCE BRADYCARDIA.

    Description of Event or Problem · 1

    THE AUDIBLE SOUND ASSOCIATED WITH THE TIME WAS LOST DURING A PASSIVE VENTING (AIRWAY) CASE. THERE WAS NO REPORTED ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750622 TRUFREEZE CRYOSPRAY SYSTEM UNIT, CRYOSURGICAL, ACCESSORIES GEH CSA MEDICAL INC CC3-01

    Patients

    Seq Age Sex Outcome Treatment
    1