BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUNNELL JET VENTILATOR

    MDR report key: 12057349 · Received June 24, 2021

    Report

    Report Number
    12057349
    Event Type
    Malfunction
    Date Received
    June 24, 2021
    Date of Event
    June 8, 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 ALARMING, (CHECK CIRCUIT TEMP.) NO TEMPERATURE ON PANEL NOTED. CIRCUIT COLD TO TOUCH. TROUBLESHOOTING DONE AND THEN, JET SWITCHED OUT. JET VENTILATOR WAS PULLED FROM PATIENT BEDSIDE AND REPLACED WITH ADDITIONAL VENT. BUNNELL WAS CALLED AND VENTILATOR WAS RETURNED TO THEM. THIS BUNNELL JET VENT WAS REPLACED WITH ANOTHER VENT AND SENT IT TO COMPANY FOR REPAIR. SERVICE REPORT STATES NO REPAIR REQUIRED - PASSED ALL TESTING SPECIFICATIONS - OPERATING CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    956701 BUNNELL JET VENTILATOR VENTILATOR, HIGH FREQUENCY LSZ BUNNELL INCORPORATED

    Patients

    Seq Age Sex Outcome Treatment
    1 365 DA