BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PURITAN BENNETT

    MDR report key: 492652 · Received October 30, 2003

    Report

    Report Number
    492652
    Event Type
    Malfunction
    Date Received
    October 30, 2003
    Date of Event
    June 1, 2003
    Report Date
    July 1, 2003
    Manufacturer
    NELLCOR-PURITAN BENNETT
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RESPIRATORY THERAPIST NOTICED 5 CM SETTING DURING VENT CHECK. NO PEEP WAS ORDERED FOR PT. THERAPIST RESET PEEP VALVE TO O CM. THERAPIST CHECKED UP AND VENT LATER, THE PEEP WAS AT 5 CM. THERAPIST REMOVED VENTILATOR FROM PT AND REPORTED PROBLEM TO RESPIRATORY SUPERVISOR. RESPIRATORY SUPERVISOR BROUGHT THE VENTILATOR TO CLINICAL ENGINEERING FOR EVAL. BIOMEDICAL TECH PERFORMED EXTENDED SELF TEST, "EST" PASSED. VENTILATOR WAS RUN AT STANDARD SETTINGS WITH TEST LUNG; PEEP WAS SET TO 0 CM. BIOMED TECH OBSERVED PEEP VALVE CHANGE TO 5 CM. TECH CALLED TECHNICAL SUPPORT TO DISCUSS PROBLEM; A SERVICE CALL WAS PLACED TO REPAIR THE VENTILATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PURITAN BENNETT VENTILATOR CBK NELLCOR-PURITAN BENNETT 7200AC *

    Patients

    Seq Age Sex Outcome Treatment
    1 *