BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 4171307 · Received October 14, 2014

    Report

    Report Number
    2031642-2014-01212
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Report Date
    September 17, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE: (B)(6) 2014. MANUFACTURE DATE: 11/21/2014. CONCLUSION / ROOT CAUSE: THE POWER SUPPLY WAS TESTED AND NO FAILURES WERE IDENTIFIED. THIS REPORT IS BEING SUBMITTED AS PART OF THE REMEDIATION FOR CAPA (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEVICE ALARMED AND WENT VENT INOP WHILE IN USE. THE CUSTOMER REPORTED NO PATIENT HARM. VENT INOP SIGNALS THE OPERATOR THAT THE VENTILATOR IS NOT CAPABLE OF SUPPORTING VENTILATION AND REQUIRES SERVICE. DURING A VENT INOP CONDITION, THE VENTILATOR ENTERS A SAFE STATE, WHERE THE SAFETY VALVE IS OPENED AND NEW ALARM CONDITION DETECTION IS DISCONTINUED. IF THE VENTILATOR IS ATTACHED TO A PATIENT WHEN THIS CONDITION IS DETECTED, THE VENTILATOR MUST BE REPLACED IMMEDIATELY. THE MANUFACTURERS FIELD SERVICE ENGINEER (FSE) WAS ABLE TO DUPLICATE THE REPORTED PROBLEM. THE FSE REPORTED WHEN THE UNIT WAS POWERED ON, IT WOULD GO VENT INOP DUE TO A POWER ON SELF TEST (POST) TIMER/24 VOLT FAILURE. THE FSE REPLACED THE POWER SUPPLY. THE FIELD SERVICE ENGINEER (FSE) NOTED THE BACKUP AND EXTERNAL BATTERIES WERE DEPLETED. THE CUSTOMER DECLINED REPLACEMENT OF THE BACKUP AND EXTERNAL BATTERIES. APPLICABLE FINAL TESTING WAS PERFORMED PER OPERATING SPECIFICATIONS AND PASSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650183 ESPRIT VENTILATOR VENTILATOR CBK RESPIRONICS CALIFORNIA, INC. V1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1