BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECHRIST INDUSTRIES, INC.

    MDR report key: 20306383 · Received September 25, 2024

    Report

    Report Number
    2020676-2024-00015
    Event Type
    Malfunction
    Date Received
    September 25, 2024
    Date of Event
    August 23, 2024
    Report Date
    November 7, 2024
    Manufacturer
    SECHRIST INDUSTRIES, INC.
    Product Code
    DTX
    PMA / PMN Number
    K023745
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INCIDENT WAS REPORTED TO SECHRIST BY OUR EUROPEAN DISTRIBUTOR-LIVANOVA. THIS REPORT IS BASED ON THE INFORMATION WE WERE PROVIDED AT THIS TIME. WE HAVE REQUESTED ADDITIONAL INFORMATION SO WE CAN COMPLETE OUR INVESTIGATION. AT THIS TIME, THERE IS NOT EVIDENCE THAT OUR DEVICE WAS THE CAUSE OF THE SUDDEN LOSS OF OXYGEN SUPPLY DURING THE CARDIAC SURGERY. THE AGE OF THE DEVICE IS PASSED ITS USEFUL LIFE. THE UNIT IS NOT SERVICED BY SECHRIST AND WILL NOT BE RETURNED TO SECHRIST FOR EVALUATION SO WE HAVE REQUESTED SERVICE REPORTS TO BE PROVIDED. THE INCIDENT WAS REPORTED IN THE EU AS A VIGILANCE REPORT TO THE GERMAN COMPETENT AUTHORITY. SECHRIST IS REPORTING BASED ON THE REPORTED ISSUE OF "SUDDEN LOSS OF OXYGEN SUPPLY" ONLY AS WE HAVE NOT COMPLETED OUR INVESTIGATION AS TO IF OUR DEVICE WAS THE ACTUAL CAUSE OF THIS OCCURRENCE. MANUFACTURER REFERENCE FILE NO.: (B)(4).

    Additional Manufacturer Narrative · 0

    EVALUATION OF DEVICE BY THIRD PARTY WAS RECEIVED ON 11/07/2024. DEVICE WAS CONFIRMED TO BE FUNTIONING AS INTENDED. THE REPORTED ISSUE COULD NOT BE REPLICATED OR CONFIRMED. THEREFORE, OUR DEVICE DID NOT CONTRIBUTE TO THE REPORTED MALFUNCTION WHICH ACCOUNTED FOR THE PATIENT INCIDENT. MANUFACTURER REFERENCE FILE NO.: (B)(4).

    Description of Event or Problem · 0

    AS REPORTED BY EUROPEAN DISTRIBUTOR FROM CUSTOMER: "QUESTIONABLE DEFECT OF THE VAPORIZER OR GAS BLENDER. SUDDEN ACUTE FAILURE OT THE OXYGEN SUPPLY DURING CARDIAC SURGERY OPERATION ON A 0-YEAR OLD PATIENT. THE PATIENT WAS IN THE MIDDLE OF THE OPERATION, HEART HAD ALREADY BEEN STOPPED WITH MEDICATION AND CUT OPEN, THERE WAS AN ACUTE RISK TO LIFE DUE TO THE FAILURE OF OXYGEN SUPPLY. THE MEDICAL STAFF THEN SWITCHED BACK AND FORTH SEVERAL TIMES BETWEEN OXYGEN BOTTLE AND THE WALL SUPPLY. AFTER SWITCHING TO ANOTHER TRAFFIC LIGHT VIA GAS BLENDER OF THE ECLS, THE PROBLEM COULD BE SOLVED AT SHORT NOTICE. OXYGEN SUPPLY IS ABSOLUTELY UNSUITABLE FOR CHILDREN OF THIS SIZE VIA OXYGEN BOTTLE. SO IT IS NOT A PERMANENT SOLUTION. SHORT-TERM SURGERY TERMINATION AND MANUAL RESUSCITATION BY CHEIF PHYSICIAN. QUESTIONABLE DEFECT OF THE VAPORT OR GAS BLENDER. HOSES ARE VISUALLY POROUS, BUT VAPOR CAN STILL BE MOVED WHEN SECURED. AFTER THE END OF OPERATION, THE FIO2 VALVE WAS CHECKED BY ANESTHESIOLOGIST ALL WITHOUT ANY ABNORMALITIES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1199306 SECHRIST INDUSTRIES, INC. OXYGEN/AIR BREATHING GAS MIXER, HOSPITAL DTX SECHRIST INDUSTRIES, INC. 20090

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other