BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURITAN BENNETT VENTILATOR

    MDR report key: 1962604 · Received January 11, 2011

    Report

    Report Number
    MW5018982
    Event Type
    Injury
    Date Received
    January 11, 2011
    Date of Event
    December 9, 2010
    Report Date
    January 11, 2011
    Manufacturer
    COVIDIEN
    Product Code
    BTM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT IS A (B)(6) OLD FEMALE. ON (B)(6) 2010, AT 2045, THE VENTILATOR SCREEN WENT BLANK. ALARM STARTED; BACK UP VENTILATION DID NOT BEGIN. REGISTERED NURSE AT THE BEDSIDE AND STARTED IMMEDIATE BAGGING OF PT. RESPIRATORY CARE PRACTITIONER AT BEDSIDE TURNED VENTILATOR OFF AND ON TWICE. UNABLE TO RESTART VENTILATOR. SCREEN REMAINED BLANK. RCP CHECKED OUTPUT, THERE WAS NO AIR FLOW. VENTILATOR REPLACED. DATES OF USE: (B)(6) 2010. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PURITAN BENNETT VENTILATOR VENTILATOR BTM COVIDIEN 840

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Life Threatening| S