BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOSONIC

    MDR report key: 10005092 · Received April 28, 2020

    Report

    Report Number
    10005092
    Event Type
    Malfunction
    Date Received
    April 28, 2020
    Date of Event
    January 5, 2020
    Report Date
    January 23, 2020
    Manufacturer
    PARKER LABORATORIES, INC.
    Product Code
    MUI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AQUASONIC ULTRASOUND TRANSMISSION GEL WARMER MACHINE HAD WARMED THE GEL TOO HIGH WHERE THE NURSE'S LEFT HAND WAS BURNT WHEN USING IT. NO GEL CAME IN CONTACT WITH THE PATIENT. THE RN REQUIRED AN ICE PACK AFTER THE INCIDENT BUT DENIED ADDITIONAL MEDICAL TREATMENT. NO BLISTERING WAS REPORTED. THE WARMING UNIT WAS SEQUESTERED BY BIOMEDICAL ENGINEERING AND WAS TESTED. IT WAS HEATING TO 153 DEGREES F AND OVER WITHOUT THE PRESENCE OF ALARMS, ERRORS, OR AUTOMATIC SHUT-OFF. MANUFACTURER RESPONSE FOR WARMER, GEL, THERMOSONIC (PER SITE REPORTER). THE MANUFACTURER WAS NOTIFIED. IF REQUESTED, THE UNIT WILL BE SENT IN FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467792 THERMOSONIC MEDIA, COUPLING, ULTRASOUND MUI PARKER LABORATORIES, INC. 82-03

    Patients

    Seq Age Sex Outcome Treatment
    1