BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 2083269 · Received May 10, 2011

    Report

    Report Number
    2031642-2011-00144
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    February 1, 2011
    Report Date
    April 13, 2011
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    WHILE SERVICING THE VENTILATOR, THE MANUFACTURER'S SERVICE TECHNICIAN NOTED A DIAGNOSTIC CODE IN THE VENTILATOR'S LOG HISTORY INDICATING A 24/+-12V/POWER FAIL CONDITION. THE CUSTOMER DID NOT REPORT THE OCCURRENCE DURING ANY PREVIOUS USAGE AND THERE WAS NO PATIENT HARM REPORTED. THE UNIT WAS NO LONGER UNDER WARRANTY SO THE CUSTOMER GAVE THE UNIT TO A 3RD PARTY SERVICE GROUP FOR NON-WARRANTY REPAIR. THE 3RD PARTY SERVICE GROUP REPORTED TO THE MANUFACTURER'S SERVICE TECHNICIAN THAT THE VENTILATOR'S BACKUP BATTERY WAS NOT FUNCTIONING AND IT WOULD BE REPLACED TO ADDRESS THE FINDING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1