BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIRD PRODUCTS CORP

    MDR report key: 367961 · Received December 19, 2001

    Report

    Report Number
    367961
    Event Type
    Injury
    Date Received
    December 19, 2001
    Date of Event
    December 6, 2001
    Report Date
    December 11, 2001
    Manufacturer
    BIRD PRODUCTS CORP
    Product Code
    CBK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS ADMITTED TO THE INTENSIVE CARE UNIT ON NOVEMBER 30, 2001 WITH AN ADMITTING DIAGNOSIS OF RIGHT PLEURAL EFFUSION. PT WAS PLACED ON A VENTILATOR TO ASSIST WITH BREATHING. AT 10:00 O'CLOCK A.M. ON EVENT DATE THE VENTILATOR FAILED TO FUNCTION AND AN ALARM ALERTED THE STAFF ON DUTY WHO RUSHED TO PT'S AID. MANUAL EQUIPMENT WAS USED TO VENTILATE THE PT WHILE THE DEFECTIVE VENTILATOR WAS DISCONNECTED AND REPLACED WITH ANOTHER VENTILATOR. NO PT INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57656 BIRD PRODUCTS CORP VENTILATOR CBK BIRD PRODUCTS CORP 8400 STI 15404 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Life Threatening| R