BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIWAZE CLEAR SYSTEM

    MDR report key: 21558901 · Received March 10, 2025

    Report

    Report Number
    21558901
    Event Type
    Malfunction
    Date Received
    March 10, 2025
    Date of Event
    January 11, 2025
    Report Date
    January 28, 2025
    Manufacturer
    ABMRC LLC
    Product Code
    NHJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE RESPIRATORY THERAPIST WAS USING A BIWAZE CLEAR SYSTEM ON A PATIENT AND SEVEN MINUTES INTO THE TREATMENT WHEN THE BIWAZE MACHINE MADE A MILD GRINDING SOUND. THE RESPIRATORY THERAPIST REPORTED COULD SMELL A BURNING-TYPE OF ODOR. THIRTY SECONDS LATER, THE RESPIRATORY THERAPIST COULD SEE CLEAR SMOKE COMING FROM THE SIDE OF THE BIWAZE MACHINE. THE MACHINE WAS TURNED OFF AND UNPLUGGED IMMEDIATELY. THERE WAS NO PATIENT INJURY. MACHINE WAS REMOVED FROM THE PATIENT'S ROOM AND ANOTHER ONE WAS OBTAINED. THE DEFECTIVE BIWAZE WAS SENT TO BIOMEDICAL ENGINEERING. DEVICE WAS SEQUESTERED AND BIOMEDICAL ENGINEERING CONTACT THE MANUFACTURER. THE DEVICE WAS PROMPTLY RETURNED TO AND REPLACED BY THE VENDOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1174238 BIWAZE CLEAR SYSTEM DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT NHJ ABMRC LLC BK181

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Female