BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFECARE

    MDR report key: 96049 · Received June 5, 1997

    Report

    Report Number
    1718784-1997-00017
    Event Type
    Death
    Date Received
    June 5, 1997
    Date of Event
    May 5, 1997
    Report Date
    June 5, 1997
    Manufacturer
    RESPIRONICS COLORADO, INC
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 05/12/97, RESPIRONICS BECAME AWARE THAT A PATIENT HAD EXPIRED WHILE USING A LIFECARE PVV VENTILATOR. APPARENTLY, THE CAREGIVER TURNED THE MACHINE OFF TO SUCTION THE PATIENT AND NEGLECTED TO TURN THE VENTILATOR BACK ON. THE MACHINE WAS PICKED UP BY THE LOCAL SHERIFF'S DEPARTMENT FOR SUBSEQUENT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFECARE PORTABLE VOLUME VENTILATOR CBK RESPIRONICS COLORADO, INC PVV NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death