BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULMONETIC

    MDR report key: 2971442 · Received October 4, 2007

    Report

    Report Number
    2031702-2007-00164
    Event Type
    Malfunction
    Date Received
    October 4, 2007
    Report Date
    October 4, 2007
    Manufacturer
    PULMONETIC SYSTEMS, INC.
    Product Code
    CBK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A BIOMEDICAL TECHNICIAN REPORTED. THE CUSTOMER SENT THE UNIT IN FOR AN OPERATIONAL INSPECTION. WHILE TESTING UNIT, VENT SHUT DOWN THREE TIMES ON TEST BENCH. UNIT SHUT DOWN WITH NO ALARMS". NO REPORT OF PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULMONETIC VOLUME VENTILATOR CBK PULMONETIC SYSTEMS, INC. LTV 1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1