BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUNNELL PATIENT CIRCUIT

    MDR report key: 10374860 · Received August 6, 2020

    Report

    Report Number
    1719232-2020-00003
    Event Type
    Malfunction
    Date Received
    August 6, 2020
    Report Date
    August 3, 2020
    Manufacturer
    BUNNELL, INC.
    Product Code
    LSZ
    PMA / PMN Number
    P850064
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING FILED IN RESPONSE TO A REQUEST RECEIVED FROM THE FDA FOR ADDITIONAL INFORMATION RELATED TO USER FACILITY REPORT (B)(4). THIS EVENT WAS NOT PREVIOUSLY REPORTED TO BUNNELL. ADDITIONAL INFORMATION WAS NOT AVAILABLE FROM THE USER FACILITY. USER FACILITY DID NOT RETURN THE DISPOSABLE IN QUESTION TO BUNNELL FOR INVESTIGATION. NO INVESTIGATION WAS POSSIBLE. AS REPORTED BY THE USER FACILITY, THERE WAS NO IMPACT TO THE PATIENT DUE TO THIS EVENT.

    Description of Event or Problem · 1

    AS REPORTED IN USER FACILITY REPORT (B)(4): "LEAKING HIGH FLOW JET RENTAL CAUSING LARGE PUDDLE FROM THE BACK OF THE UNIT. JET REPLACED. VENTILATOR HAD A FAULTY CARTRIDGE WHICH ALLOWED FOR LEAKING OF WATER. THE VENTILATOR WAS RE-CALIBRATED WITH NEW CARTRIDGE, CIRCUIT ETC. AND NO ISSUES WERE NOTED. THE VENTILATOR HAS SINCE BEEN RETURNED TO BUNNELL. UNFORTUNATELY, WE DO NOT HAVE DEVICE IDENTIFIERS. NO HARM TO PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838652 BUNNELL PATIENT CIRCUIT BUNNELL PATIENT BREATHING CIRCUIT (PBC) LSZ BUNNELL, INC. 00212 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1