BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPIRIT

    MDR report key: 3833621 · Received May 21, 2014

    Report

    Report Number
    MW5036211
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    April 17, 2014
    Report Date
    May 13, 2014
    Manufacturer
    PHILIPS RESPIRONICS
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    VENTILATOR ALARM BEGAN ALARMING WITH TIDAL VOLUMES IN THE 100'S. SET VOLUME WAS 400. A LOUD VENT ALARM BEGAN TO GO OFF CONSISTENTLY WITHOUT DEFINITION ON VENT AS TO THE REASON FOR THAT PARTICULAR ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301178 ESPIRIT VENTILATOR CBK PHILIPS RESPIRONICS ESPIRIT

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR