BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 1821618 · Received August 31, 2010

    Report

    Report Number
    2031642-2010-00238
    Event Type
    Malfunction
    Date Received
    August 31, 2010
    Date of Event
    July 27, 2010
    Report Date
    August 4, 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

    Additional Manufacturer Narrative · 1

    BATTERY

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR SHUT DOWN AND ALARMED DURING TRANSPORT OF THE PATIENT FROM THE SHOWER TO THE PATIENT'S ROOM. THE CUSTOMER REPORTED THERE WAS NO PATIENT HARM. THE CUSTOMER REPORTED THAT THE VENTILATOR WAS OPERATING VIA EXTERNAL BATTERY POWER WHICH DEPLETED UPON EXTENDED USE, AND WHEN THE VENTILATOR WENT TO TRANSITION TO THE BACKUP BATTERY IT SHUT DOWN BECAUSE THE BACKUP BATTERY WAS ALREADY DEPLETED FROM EXTENDED USE. THE MANUFACTURER'S FIELD SERVICE TECHNICIAN CONFIRMED THE EXTERNAL AND BACKUP BATTERY WAS FULLY DEPLETED AND WOULD NOT HOLD A CHARGE. THE SERVICE TECHNICIAN REPORTED BOTH BATTERIES WERE 5 YEARS OLD. THE SERVICE TECHNICIAN REPLACED BOTH BATTERIES TO COMPLETE THE SERVICE. EXTENDED SELF TESTING (EST) AND PERFORMANCE VERIFICATION TESTING WAS COMPLETED AND TESTS PASSED TO OPERATING SPECIFICATIONS. THIS EVENT IS BEING REPORTED AS A USER ERROR DUE TO FAILURE TO TEST AND MAINTAIN THE BATTERIES AS SPECIFIED.

    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