BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULMONETIC

    MDR report key: 1163699 · Received September 9, 2008

    Report

    Report Number
    2031702-2008-00172
    Event Type
    Malfunction
    Date Received
    September 9, 2008
    Date of Event
    August 15, 2008
    Report Date
    September 9, 2008
    Manufacturer
    CARDINAL HEALTH 203/PULMONETIC SYSTEMS, INC.
    Product Code
    CBK
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR SHUT DOWN WITH AN AUDIBLE INOP ALARM WHILE ON A PATIENT. THE PATIENT, WHO USES THE VENTILATOR FOR NIGHTTIME USE ONLY, REMOVED HIMSELF FROM THE VENTILATOR. NO REPORTED HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULMONETIC VOLUME VENTILATOR CBK CARDINAL HEALTH 203/PULMONETIC SYSTEMS, INC. LTV 950 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR