BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUNNELL JET

    MDR report key: 12057753 · Received June 24, 2021

    Report

    Report Number
    12057753
    Event Type
    Malfunction
    Date Received
    June 24, 2021
    Date of Event
    May 10, 2020
    Report Date
    June 15, 2021
    Manufacturer
    BUNNELL, INCORPORATED
    Product Code
    LSZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    BUNNELL JET SHUT DOWN AND COULD NOT BE RESTARTED. VENTILATOR WAS PLACED ON PATIENT AND THEN SHUT DOWN DURING USE. VENTILATOR WAS UNABLE TO BE RESTARTED. VENT. REMOVED FROM PATIENT AND WORK ORDER PLACED. NO HARM TO PATIENT. POWER BREAKER IN THE BACK OF VENT WAS OFF. THIS BUNNELL JET IS A RENTAL, DOES NOT BELONG TO OUR FACILITY AND IS NOT MAINTAINED BY CLINICAL ENGINEERING. NO FURTHER ACTION REQUIRED BY CLINICAL ENGINEERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    956269 BUNNELL JET VENTILATOR, HIGH FREQUENCY LSZ BUNNELL, INCORPORATED

    Patients

    Seq Age Sex Outcome Treatment
    1 365 DA