BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULMONETIC

    MDR report key: 427770 · Received November 8, 2002

    Report

    Report Number
    2031702-2002-00225
    Event Type
    Malfunction
    Date Received
    November 8, 2002
    Date of Event
    October 4, 2002
    Report Date
    November 8, 2002
    Manufacturer
    PULMONETIC SYSTEMS, INC.
    Product Code
    CBK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    COMPANY RECEIVED AN EMAIL FROM A REPRESENTATIVE IN 10/2002. THE REPRESENTATIVE REPORTED THE FOLLOWING PROBLEM: VENT INOP FOR A SHORT PERIOD OF TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other