BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFREEZE CRYOSPRAY SYSTEM

    MDR report key: 4951967 · Received July 30, 2015

    Report

    Report Number
    3010140265-2015-00007
    Event Type
    Malfunction
    Date Received
    July 30, 2015
    Date of Event
    July 15, 2015
    Report Date
    July 30, 2015
    Manufacturer
    CSA MEDICAL INC.
    Product Code
    GEH
    PMA / PMN Number
    K152668
    Removal / Correction Number
    9062377-11/10/14-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION CONCLUSION - COMPONENT FAILURE (SOUND DRIVER).

    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 TECHNICIAN 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 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 TONE. IN A PASSIVE VENTING PROCEDURE, THIS POTENTIAL EXCESS CRYOGEN DELIVERY COULD INDUCE BRADYCARDIA. THE INSTRUCTIONS FOR USE HAS BEEN UPDATED TO INCLUDE "THE PHYSICIAN SHOULD KEEP TRACK OF THE DURATION OF DELIVERY BY UTILIZING THE TIMER'S AUDIBLE TONE AND BY ASSIGNING AN APPROPRIATE HEALTH CARE PROVIDER TO AUDIBLY CALL OUT THE TIMER'S SECOND BY SECOND DISPLAY UNTIL THE SELECTED LENGTH OF CRYOGEN SPRAY HAS COMPLETED." THIS PROVIDES A MITIGATION TO ADDRESS THE RARE INSTANCE OF LOSS OF AUDIBLE TONE.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    THE AUDIBLE SOUND ASSOCIATED WITH THE TIMER 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
    498817 TRUFREEZE CRYOSPRAY SYSTEM UNIT, CRYOSURGICAL, ACCESSORIES GEH CSA MEDICAL INC. CC3-01

    Patients

    Seq Age Sex Outcome Treatment
    1