BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURITAN BENNETT 840

    MDR report key: 10448138 · Received August 24, 2020

    Report

    Report Number
    MW5096224
    Event Type
    Injury
    Date Received
    August 24, 2020
    Date of Event
    August 19, 2020
    Report Date
    August 20, 2020
    Manufacturer
    MED ONE EQUIPMENT SERVICES, LLC
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2020, #(B)(6) ADMITTED IN DOU. PATIENT IS TRACH AND VENTILATOR DEPENDENT. AT 0425 PATIENT VENTILATOR (PB840) STARTED ALARMING, VENTILATOR ALARM MESSAGE " DEVICE FAILURE" VENT INOP. BAG MASK VENTILATION INITIATED, VENTILATOR REPLACED WITH NEW PB840. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910967 PURITAN BENNETT 840 VENTILATOR, CONTINUOUS, FACILITY USE CBK MED ONE EQUIPMENT SERVICES, LLC PB 840

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Life Threatening