BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULMONETIC

    MDR report key: 409887 · Received August 6, 2002

    Report

    Report Number
    2031702-2002-00114
    Event Type
    Malfunction
    Date Received
    August 6, 2002
    Date of Event
    June 25, 2002
    Report Date
    August 6, 2002
    Manufacturer
    PULMONETIC SYSTEMS, INC.
    Product Code
    CBK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    PULMONETIC SYSTEM, INC. RECEIVED A CALL FROM A REPRESENTATIVE OF NORCO IN 07/2002. THE REPRESENTATIVE REPORTED THE FOLLOWING PROBLEM: VENTILATOR SHUTTING OFF INTERMITTENTLY WITH AUDIBLE ALARM THEN REBOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULMONETIC VOLUME VENTILATOR CBK PULMONETIC SYSTEMS, INC. LTV900 *

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Other