BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULMONETIC

    MDR report key: 1051267 · Received May 22, 2008

    Report

    Report Number
    2031702-2008-00094
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Report Date
    May 22, 2008
    Manufacturer
    CARDINAL HEALTH 203/PULMONETIC SYSTEMS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K051767
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TESTING BY SERVICE CENTER FOUND THE VENTILATOR TURNED OFF WITH AN AUDIBLE ALARM ON ITS OWN DURING TESTING. REPLACED THE POWER BOARD TO CORRECT THE FAILURE MODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULMONETIC VOLUME VENTILATOR CBK CARDINAL HEALTH 203/PULMONETIC SYSTEMS, INC. LTV 1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1