BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTABLE VENTILATOR

    MDR report key: 19101 · Received January 24, 1995

    Report

    Report Number
    MW1004846
    Event Type
    Injury
    Date Received
    January 24, 1995
    Date of Event
    January 19, 1995
    Report Date
    January 23, 1995
    Manufacturer
    LIFECARE SERVICES, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN THE EXHAUST TUBING FROM THE VENTILATOR CIRCUIT BECAME DISCONNECTED, THE VENTILATOR FAILED TO ALARM. THE PT EXPERIENCED A HYPOXIC EVENT AND WAS PUT ON ANOTHER VENTILATOR, AND IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORTABLE VENTILATOR CBK LIFECARE SERVICES, INC. PLV-100

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention