BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 2211704 · Received August 15, 2011

    Report

    Report Number
    2031642-2011-00275
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 18, 2011
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR WAS ALARMING 'LOW BATTERY' AND SUBSEQUENTLY POWERED OFF WHILE IT WAS IN USE ON A PATIENT. THE CUSTOMER REPORTED THERE WAS NO PATIENT HARM. REVIEW OF THE VENTILATOR'S DIAGNOSTIC LOG VERIFIED THE DEVICE WAS OPERATING ON BACKUP BATTERY POWER AND THE BACKUP BATTERY FUNCTIONED UNTIL IT DEPLETED AS A RESULT OF USE, AT WHICH TIME THE VENTILATOR WILL SHUT DOWN AND ALARM AS SPECIFIED DUE TO LOSS OF POWER. THE MANUFACTURER'S SERVICE TECHNICIAN WAS UNABLE TO DUPLICATE THE REPORTED EVENT. THE SERVICE TECHNICIAN REPLACED THE POWER SUPPLY AND THE BACKUP BATTERY TO ADDRESS THE REPORTED EVENT. APPLICABLE FINAL TESTING WAS COMPLETED AND TESTS PASSED TO OPERATING SPECIFICATIONS. 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