BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULMONETIC

    MDR report key: 412580 · Received August 19, 2002

    Report

    Report Number
    2031702-2002-00121
    Event Type
    Malfunction
    Date Received
    August 19, 2002
    Report Date
    August 16, 2002
    Manufacturer
    PULMONETIC SYSTEMS, INC.
    Product Code
    CBK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PULMONETIC SYSTEMS, INC. RECEIVED A CALL FROM A REPRESENTATIVE OF HEALTHCARE, ON 07/19/02, REPORTING THE FOLLOWING PROBLEM: UNIT SHUTS DOWN BY ITSELF WITH ALARM. CUSTOMER CONTACTED ON 8/15/02 TO VERIFY STATUS OF UNIT.

    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