BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 3895851 · Received June 26, 2014

    Report

    Report Number
    2031642-2014-00558
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Report Date
    May 28, 2014
    Manufacturer
    REPIRONICS CALIFORNIA, INC
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE BACKUP BATTERY FAILED DURING PREVENTIVE MAINTENANCE. THE MANUFACTURER'S FIELD SERVICE ENGINEER (FSE) CONFIRMED THE REPORTED PROBLEM. IF A LOSS OF POWER OCCURS DURING USE DUE TO THE BACKUP BATTERY NOT WORKING IT COULD CAUSE THE UNIT TO SHUT DOWN. THE FSE REPORTED THE BACKUP BATTERY WAS DATED 2007. THE FSE REPLACED THE BACKUP BATTERY TO CORRECT THE REPORTED PROBLEM. THE DEVICE PASSED ALL MANUFACTURERS REQUIRED TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374249 ESPRIT VENTILATOR VENTILATOR, CONTINUOUS CBK REPIRONICS CALIFORNIA, INC V1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1