BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 3895844 · Received June 26, 2014

    Report

    Report Number
    2031642-2014-00557
    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
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    AFTER PREVENTIVE MAINTENANCE SERVICE, THE MANUFACTURER'S FIELD SERVICE ENGINEER (FSE) REPORTED THE EXTERNAL BATTERY FAILED THE OPERATIONAL TEST. THE FSE RECOMMENDED PLUGGING THE VENTILATOR INTO AC POWER FOR AT LEAST 12 HOURS AND RETESTING. THE CUSTOMER REPORTED THE BATTERY DID NOT CHARGE AFTER THE FSE RECOMMENDATION. THE CUSTOMER DECLINED REPLACEMENT OF THE EXTERNAL BATTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374884 ESPRIT VENTILATOR VENTILATOR, CONTINUOUS CBK REPIRONICS CALIFORNIA, INC V1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1