BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 2071176 · Received April 27, 2011

    Report

    Report Number
    2031642-2011-00121
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 31, 2011
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR ALARMED AND MONITOR SCREEN WENT BLANK WHILE OPERATING VIA EXTERNAL BATTERY DURING USE ON A PATIENT. THE CUSTOMER REPORTED THERE WAS NO PATIENT HARM. THE MANUFACTURER'S SERVICE TECHNICIAN WAS UNABLE TO DUPLICATE THE REPORTED EVENT. REVIEW OF THE VENTILATOR LOG HISTORY NOTED A DIAGNOSTIC CODE THAT INDICATED A +24 VOLT POWER FAIL CONDITION HAD OCCURRED. PER SPECIFICATION, WHEN THE EXTERNAL BATTERY IS DEPLETED, THE VENTILATOR SWITCHES OVER TO BACKUP BATTERY POWER. THE SERVICE TECHNICIAN REPORTED THE VENTILATOR PERFORMED ACCORDINGLY. EXTENDED SELF TESTING (EST) AND APPLICABLE FINAL TESTING WAS COMPLETED AND TESTS PASSED TO SPECIFICATIONS. PROPER CARE, MAINTENANCE AND TESTING SHOULD BE PERFORMED WHEN USING BATTERY POWER SOURCES. PER THE OPERATORS MANUAL, BATTERY OPERATING LIFE DEPENDS ON BATTERY AGE. OVER TIME THE BATTERY DEGENERATES AND PROVIDES LESS OPERATING TIME PER CHARGE THAN A FULLY CHARGED NEW BATTERY. IN ADDITION, WHEN THE BATTERY IS IN USE, THE VENTILATOR ALARMS INDICATING THE BATTERY IS THE POWER SOURCE FOR VENTILATOR OPERATION. THE USER SHOULD IMMEDIATELY CONNECT AC POWER OR PROVIDE AN ALTERNATE MEANS OF VENTILATION.

    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