BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESPRIT

    MDR report key: 2822546 · Received October 22, 2012

    Report

    Report Number
    2822546
    Event Type
    Injury
    Date Received
    October 22, 2012
    Date of Event
    September 17, 2012
    Report Date
    October 22, 2012
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    PATIENT ON ESPRIT VENTILATOR FOR 7 DAYS. PATIENT WAS TAKEN TO OR FOR TRACHEOTOMY AND RETURNED TO ICU AND PLACED BACK ON THE VENTILATOR. EXTERNAL BATTERY LOW INDICATOR WAS PRESENT ON THE VENTILATOR WHILE IT WAS PLUGGED INTO AC OUTLET. VENTILATOR STOPPED FUNCTIONING, ALARMS SOUNDED - PATIENT TAKEN OFF VENTILATOR AND MANUALLY BAGGED UNTIL PLACED ON A REPLACEMENT VENTILATOR AT. NO HARM TO PATIENT. PATIENT ON FOLLOWING VENTILATOR SETTINGS: .30 CPAP 5 PS 5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESPRIT VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS CALIFORNIA, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention