BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E200 VENTILATOR

    MDR report key: 3001621 · Received March 11, 2013

    Report

    Report Number
    2023050-2013-00163
    Event Type
    Injury
    Date Received
    March 11, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 11, 2013
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS
    Product Code
    CBK
    PMA / PMN Number
    K901785
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THROUGH REQUESTED, PATIENT INFORMATION WAS NOT PROVIDED.

    Description of Event or Problem · 1

    DURING PATIENT USE, 'LOW MINUTE VOLUME' ALARM AND 'LOW AIRWAY PRESSURE' ALARM OCCURRED. THE NURSE CONFIRMED THAT THE VENTILATOR STOPPED VENTILATING. THE PATIENT WAS AMBU BAGGED AND SWITCHED TO ANOTHER VENTILATOR. LATER, A MEDICAL ENGINEER TESTED THE VENTILATOR WITH A TEST LUNG CONFIRMING THAT THE TEST LUNG WAS NOT INFLATING. HOWEVER, IT STARTED VENTILATING AFTER 5 MINUTES. NO PERMANENT INJURY WAS REPORTED IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101949 E200 VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS E200

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention