BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULMONETIC

    MDR report key: 970639 · Received December 28, 2007

    Report

    Report Number
    2031702-2007-00225
    Event Type
    Malfunction
    Date Received
    December 28, 2007
    Date of Event
    November 19, 2007
    Report Date
    December 28, 2007
    Manufacturer
    CARDINAL HEALTH 203/PULMONETRIC SYSTEMS, INC
    Product Code
    CBK
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR 2031702-207-0225 IS BEING FILED BEYOND THE 30 DAY REPORTING TIMELINE.

    Description of Event or Problem · 1

    UNIT ALLEGEDLY SHUT DOWN AND THEN RESTARTED ON A PT. THERE WAS NO REPORT OF PT HARM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR