BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULMONETIC

    MDR report key: 500703 · Received November 26, 2003

    Report

    Report Number
    2031702-2003-00338
    Event Type
    Malfunction
    Date Received
    November 26, 2003
    Report Date
    November 26, 2003
    Manufacturer
    PULMONETIC SYSTEMS, INC.
    Product Code
    CBK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PULMONETIC SYSTEMS, INC. RECEIVED THE FOLLOWING REPORT FROM A REP: VENT SHUT OFF TWICE, NO ALARM.

    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