BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASOUND IMAGING WITH TI 3-6

    MDR report key: 10239454 · Received July 6, 2020

    Report

    Report Number
    MW5095394
    Event Type
    Malfunction
    Date Received
    July 6, 2020
    Report Date
    July 1, 2020
    Manufacturer
    UNK
    Product Code
    IYO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PR, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    OBSTETRIC ULTRASOUND DEVICES THAT ALLOW HEALTH PROVIDERS TO PRODUCE AN IRRADIATION WITH A THERMAL INDEX ABOVE 40 DEGREES C (TI 3-6) COULD TRIGGER AN ENZYMATIC COLLAPSE. DENATURATION AND ENZYME DEPLETION CAN RESULT FROM OVERHEATING CAUSED BY DEEP HIGH FREQUENCY ULTRASOUND. VITAL BODY SYSTEMS AND PROCESSES IN EMBRYO-FETUS WILL BE INTERRUPTED. LIFE CHANGING OR LIFE THREATENING CONSEQUENCES CAN BE EXPECTED IN NEONATES. FOR MOST HUMAN ENZYMES TEMPERATURES ABOVE 40 DEGREES C EXCEED THEIR STRUCTURAL DESIGN (MELTING TEMPERATURE), 40 DEGREES C IS A DEATH ZONE FOR ENZYMES. SUGGESTION LIKE ALARA AND ESTIMATION LIKE THERMAL INDEX DON'T PROVIDE A PHYSICAL MECHANISM TO MEASURE EMBRYO-FETUS REAL TIME CORE TEMPERATURE. THIS CAN BE EASILY PREVENTED BY AVOIDING EMBRYO-FETUS EXPOSURE TO TEMPERATURES OVER 40 DEGREES C AND NON OBSTETRIC ULTRASOUND IRRADIATION DEVICE CAN BE ALLOWED TO PRODUCE TEMPERATURE INCREASES OVER 40 DEGREES C. FROM MITOCHONDRIA TO GUTS ENZYMES DENATURATION CAN PRODUCE CATASTROPHIC EFFECTS IN NEONATES. DOES EFFECTS ARE ACCOUNTED SEPARATELY BUT THEY SHARE A COMMON, HEAT OVER EXPOSURE. "ANY COMPANY EQUIPMENT TI 3-6". FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695603 ULTRASOUND IMAGING WITH TI 3-6 SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other