BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIV 102

    MDR report key: 348887 · Received August 28, 2001

    Report

    Report Number
    348887
    Event Type
    Death
    Date Received
    August 28, 2001
    Date of Event
    July 5, 2001
    Report Date
    August 10, 2001
    Manufacturer
    RESPIRONICS COLORADO
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    T-ADAPTER LEFT IN PLACE AFTER NEBULIZED MEDICATION ADMINISTERED WHICH VENTED TO ROOM AIR. HME FILTER DID NOT REGISTER A DISCONNECT AND NO ALARM SOUNDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39094 PIV 102 VOLUME VENTILATOR CBK RESPIRONICS COLORADO 102 *

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death