BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULMONETIC

    MDR report key: 563788 · Received January 4, 2005

    Report

    Report Number
    2031702-2004-00327
    Event Type
    Malfunction
    Date Received
    January 4, 2005
    Report Date
    December 29, 2004
    Manufacturer
    PULMONETIC SYSTEMS, INC.
    Product Code
    CBK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LTV DID NOT REACT TO KEY OPERATION, AND RESET ALARM OCCURRED. SOME DOTS OF LED DISPLAY WERE DISAPPEARED.

    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 UNKNOWN Other