BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 2223672 · Received August 25, 2011

    Report

    Report Number
    2031642-2011-00280
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 4, 2011
    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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR LOST POWER DURING TESTING. REVIEW OF THE VENTILATOR'S DIAGNOSTIC LOG VERIFIED THE DEVICE HAD BEEN IN OPERATION ON BACKUP BATTERY POWER AND THE BACKUP BATTERY FUNCTIONED UNTIL IT DEPLETED AS A RESULT OF EXTENDED USE, AT WHICH TIME THE VENTILATOR WILL SHUT DOWN AND ALARM AS SPECIFIED DUE TO LOSS OF POWER. THE MANUFACTURER'S FIELD SERVICE TECHNICIAN PERFORMED EVALUATION AND TESTING AND REPORTED FINDING THE UNIT HAD NO AC POWER SOURCE DUE TO THE POWER CORD BEING A NON-MANUFACTURER'S APPROVED POWER CORD. THE SERVICE TECHNICIAN REPORTED THE NON-MANUFACTURER'S APPROVED POWER CORD WAS CAUSING A BAD CONNECTION TO THE VENTILATOR. THE SERVICE TECHNICIAN REPORTED ALSO FINDING THE EXTERNAL BATTERY POWER SWITCH WAS TURNED OFF. WHEN THE EXTERNAL BATTERY IS TURNED OFF AND THERE IS NO AC POWER AVAILABLE, THE VENTILATOR WILL OPERATE ON BACKUP BATTERY. THE SERVICE TECHNICIAN CONFIRMED THE VENTILATOR WOULD OPERATE ON BACKUP BATTERY FOR ONLY A SHORT WHILE AND THEN SHUT OFF. THE SERVICE TECHNICIAN REPLACED THE BACKUP BATTERY TO ADDRESS THE FINDING. THE SERVICE TECHNICIAN ALSO REPLACED THE POWER CORD AND TURNED ON THE EXTERNAL BATTERY SWITCH TO ADDRESS THE USER INDUCED FINDING. EXTENDED SELF TESTING (EST) AND APPLICABLE FINAL TESTING WAS COMPLETED AND TESTS PASSED TO OPERATING SPECIFICATIONS. THIS EVENT IS BEING REPORTED AS A USER ERROR DUE TO USE OF A NON-APPROVED POWER CORD AND THE IMPROPER USE OF THE EXTERNAL BATTERY, BOTH CONDITIONS RESULTING IN THE VENTILATOR USING THE BACKUP BATTERY FOR POWER AND THE BATTERY DEPLETING DUE TO SPECIFIED EXTENDED USE. PER THE VENTILATOR'S OPERATORS MANUAL, WHEN THE VENTILATOR IS POWERED BY BACKUP BATTERY IT WILL GENERATE A NONRESETABLE, NONSILENCEABLE ALARM EVERY 60 SECONDS. DURING THIS STATE A BATTERY IN USE YELLOW LED IS LIT. OPERATION WILL CONTINUE UNTIL THE BATTERY HAS 5 MINUTES OF OPERATION LEFT. A RED BATTERY LOW LED WILL FLASH AND A NONRESETABLE HIGH PRIORITY ALARM WILL SOUND. WHEN THE BATTERY LOW INDICATOR IS FLASHING RED, OPERATION OF THE VENTILATOR FROM THE BATTERY POWER SHOULD BE DISCONTINUED.

    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