BEUDAMED
    FDA Adverse Event Death Summary report: N

    COVIDIEN PURITAN BENNETT

    MDR report key: 1642605 · Received March 23, 2010

    Report

    Report Number
    MW5015280
    Event Type
    Death
    Date Received
    March 23, 2010
    Date of Event
    February 25, 2010
    Report Date
    March 23, 2010
    Manufacturer
    COVIDIEN PURITAN BENNETT
    Product Code
    CBK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    VENTILATOR WAS SERVICED FOR PREVENTIVE MAINTENANCE ON (B) (6) 2010 AT 12:51 PM AND REPORTED SAFE FOR PATIENT USE. VENTILATOR UNIT WAS CONNECTED TO PATIENT AFTER PARAMETERS WERE SET AND CHECKED. PATIENT WAS PLACED IN THE VENTILATOR FOR 2 MINUTES WHEN THE ALARM WAS SILENCED FOR SUCTIONING. THE ALARM RESET AUTOMATICALLY IN 2 MINUTES. FIVE MINUTES LATER, THE NURSE FOUND THE VENTILATOR UNIT SWITCH IN THE 'OFF' POSITION. PATIENT WAS NOT RESUSCITATED BECAUSE THERE WAS A DO NOT RESUSCITATE ORDER IN PLACE, AND FAMILY HAD REQUESTED TRANSFER TO HOSPICE CARE. DATES OF USE: (B) (6) 2010. DIAGNOSIS OR REASON FOR USE: RESPIRATORY FAILURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death