BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUNNELL INC. LIFEPULSE 203

    MDR report key: 10185016 · Received June 23, 2020

    Report

    Report Number
    MW5095155
    Event Type
    Malfunction
    Date Received
    June 23, 2020
    Date of Event
    March 20, 2020
    Report Date
    June 19, 2020
    Manufacturer
    BUNNELL, INC.
    Product Code
    LSZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WATER FROM THE HUMIDIFIER CARTRIDGE FLOWED INTO THE PT'S CIRCUIT AND ET TUBE CAUSING THE PT TO ASPIRATE THE WATER. PATIENT DIED. ADDRESS QUESTIONS TO: (B)(6) OR TO: (B)(6). FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647588 BUNNELL INC. LIFEPULSE 203 VENTILATOR, HIGH FREQUENCY LSZ BUNNELL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 20 DA Other