BEUDAMED
    FDA Adverse Event Other Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 1725421 · Received June 11, 2010

    Report

    Report Number
    2031642-2010-00122
    Event Type
    Other
    Date Received
    June 11, 2010
    Date of Event
    May 18, 2010
    Report Date
    May 18, 2010
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED, THE VENTILATOR IS ALARMING LOW BATTERY AND THE UNIT RESTARTED. THE CUSTOMER REPORTED, THE VENTILATOR WAS IN USE ON A PATIENT AND THERE WAS NO PATIENT HARM. THE SERVICE TECHNICIAN REVIEWED THE VENTILATOR DIAGNOSTIC LOG HISTORY AND VERIFIED THAT THE BATTERY WAS DEPLETED. THE CUSTOMER STATED THAT THE UNIT WAS REMOVED FROM SERVICE AND LEFT PLUGGED IN ON AC POWER TO CHARGE THE BATTERY. THE SERVICE TECHNICIAN INSPECTED AND TESTED THE BATTERY AND NO PROBLEM WAS FOUND. NO PART WAS REPLACED. THIS EVENT IS BEING REPORTED AS A USER ERROR. FINAL APPLICABLE TESTING WAS PERFORMED AND PASSED TO OPERATING SPECIFICATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1