BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILLIPS

    MDR report key: 1180445 · Received September 23, 2008

    Report

    Report Number
    MW5008473
    Event Type
    Injury
    Date Received
    September 23, 2008
    Date of Event
    September 8, 2008
    Report Date
    September 23, 2008
    Manufacturer
    PHILLIPS HEALTHCARE
    Product Code
    CBK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT FOUND WITH SINUS BRADY, HEART RATE 30. THE NURSE IMMEDIATELY STARTED CPR AND DISCONNECTED THE PT FROM THE VENT TO AMBU. THE VENTILATOR DISCONNECT ALARM DID NOT SOUND, BUT INSTEAD THE VENT SCREEN READ, "WAITING FOR PT CONNECT." AT THAT TIME, IT WAS NOTED THE VENT HAD MALFUNCTIONED. THE PT WAS RESUSCITATED AND PLACED ON A NEW VENT BY RT. PT WAS LATER DIAGNOSED WITH ANOXIC BRAIN INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILLIPS INTELLIVUE INFORMATION CENTER CBK PHILLIPS HEALTHCARE M3155

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| L| R