BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 1882183 · Received October 25, 2010

    Report

    Report Number
    2031642-2010-00290
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    September 29, 2010
    Report Date
    September 29, 2010
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATTERY.

    Description of Event or Problem · 1

    THE RESPIRATORY THERAPY (RT) DIRECTOR REPORTED THAT THE FACILITY'S POWER WAS OUT FOR ABOUT 1/2 HOUR AND THEY HAD PROBLEMS WITH THE HOSPITAL GENERATOR DURING THE OUTAGE. THE RT DIRECTOR REPORTED THE GENERATOR WOULD COME ON AND THEN SHUT OFF. THIS OCCURRED APPROX. 3 TIMES, AND EACH TIME THE VENTILATOR WOULD TRANSITION TO BACKUP BATTERY AND THEN BACK TO THE GENERATOR WHEN IT WOULD COME ON AND PROVIDE AC POWER. AFTER THE THIRD TIME THE VENTILATOR DID NOT POWER ON VIA BACKUP BATTERY POWER WHEN THE GENERATOR TURNED BACK ON, AND SHUT DOWN AND ALARMED. THE VENTILATOR WAS ON A PATIENT DURING THIS REPORTED EVENT, AND THE CUSTOMER REPORTED THERE WAS NO PATIENT HARM. REVIEW OF THE VENTILATOR LOG HISTORY NOTED A DIAGNOSTIC CODE THAT INDICATED A +24 VOLT POWER FAIL CONDITION HAD OCCURRED, LIKELY DUE TO ATTEMPTS TO OPERATE THE VENTILATOR VIA A BACKUP BATTERY THAT IS FULLY DISCHARGED. THE VENTILATOR WILL BE UNABLE TO SUSTAIN OPERATION IF IT IS BEING POWERED VIA A DISCHARGED BATTERY. THE MANUFACTURER'S SERVICE TECHNICIAN REPLACED THE BACKUP BATTERY TO ADDRESS THE FINDINGS. EXTENDED SELF TESTING (EST) AND APPLICABLE FINAL TESTING WAS COMPLETED AND THE VENTILATOR PASSED PER OPERATING SPECIFICATIONS.

    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