BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTILATOR

    MDR report key: 444194 · Received February 21, 2003

    Report

    Report Number
    MW1027610
    Event Type
    Malfunction
    Date Received
    February 21, 2003
    Date of Event
    January 27, 2003
    Report Date
    February 11, 2003
    Manufacturer
    MALLINCKRODT INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE E.R. NURSE PLACED THE 900 MHZ PROTABLE PHONE ON TOP OF THE 840 PURITAN-BENNETT VENTILATOR. THE 840 PURITAN-BENNETT VENILATOR SYSTEM WENT IN "DEVICE ALERT" CONDITION. ERROR CODE LB0036 (ALARM CABLE ERROR) AND LB0116 (ANALOG DEVICE TEST).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTILATOR PB 840 VENTILATOR CBK MALLINCKRODT INC. 840 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA