BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 3973798 · Received August 1, 2014

    Report

    Report Number
    2031642-2014-00778
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Report Date
    July 10, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR BACKUP BATTERY WOULD NOT FUNCTION. THE DEVICE WAS NOT IN USE THEREFORE THERE WAS NO PATIENT INVOLVEMENT OR HARM. THE MANUFACTURER'S FIELD SERVICE ENGINEER (FSE) CONFIRMED THE REPORTED PROBLEM. THE FSE REPORTED THE UNIT DISPLAYED A MESSAGE 'BACKUP BATTERY NOT CONNECTED', INDICATING TO THE USER THAT THE BATTERY IN PLACE FOR BACKUP POWER HAD A LOW CAPACITY FOR USE. THE FSE REPLACED THE BATTERY TO ADDRESS THE REPORTED PROBLEM. APPLICABLE FINAL TESTING WAS COMPLETED PER OPERATING SPECIFICATIONS AND PASSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450308 ESPRIT VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1