BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULMONETIC

    MDR report key: 1024190 · Received March 27, 2008

    Report

    Report Number
    2031702-2008-00053
    Event Type
    Malfunction
    Date Received
    March 27, 2008
    Report Date
    March 26, 2008
    Manufacturer
    CARDINAL HEALTH 203/PULMONETIC SYSTEMS, INC.
    Product Code
    CBK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR 2031702-2008-00053 IS BEING FILED BEYOND THE 30 DAY REPORTING TIMELINE. THE CUSTOMER SVC REP INADVERTENTLY FAILED TO NOTIFY REGULATORY AFFAIRS.

    Description of Event or Problem · 1

    TESTING BY SERVICE CENTER FOUND THE VENTILATOR POWERS ON AND OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULMONETIC VOLUME VENTILATOR CBK CARDINAL HEALTH 203/PULMONETIC SYSTEMS, INC. LTV 900 NA

    Patients

    Seq Age Sex Outcome Treatment
    1