BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 3894925 · Received June 25, 2014

    Report

    Report Number
    2031642-2014-00551
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Report Date
    May 29, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER DECLINED REPLACMENT OF EXTERNAL BATTERY.

    Description of Event or Problem · 1

    THE MANUFACTURER'S SERVICE TECHNICIAN REPORTED DURING THE ANNUAL PREVENTATIVE MAINTENANCE THE EXTERNAL BATTERY FAILED TESTING. THE CUSTOMER DECLINED REPLACEMENT OF THE EXTERNAL BATTERY. APPLICABLE FINAL TESTING WAS PERFORMED PER OPERATING SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370395 ESPRIT VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1