BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULMONETIC

    MDR report key: 701999 · Received April 17, 2006

    Report

    Report Number
    2031702-2006-00097
    Event Type
    Malfunction
    Date Received
    April 17, 2006
    Date of Event
    February 18, 2006
    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

    THE CUSTOMER SAID, "RESET ALARM WAS OCCURRED AT 7:00AM ON 02/17/2006 AND 12:00PM ON 2/18/2006". NO ALLEGATION OF PATIENT HARM.

    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