BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 2230969 · Received September 1, 2011

    Report

    Report Number
    2031642-2011-00301
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 15, 2011
    Report Date
    August 15, 2011
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT WOULD NOT POWER ON. THE VENTILATOR WAS NOT IN USE THEREFORE THERE WAS NO PATIENT INVOLVEMENT OR HARM. THE MANUFACTURER'S SERVICE TECHNICIAN REPORTED THE VENTILATOR WOULD OPERATE ON BACKUP BATTERY POWER AND WOULD SHUT DOWN WHEN AC POWER WAS CONNECTED. THE SERVICE TECHNICIAN REPLACED THE POWER SUPPLY TO ADDRESS THE FINDING. EXTENDED SELF TESTING AND APPLICABLE FINAL TESTING WAS COMPLETED AND TESTS PASSED TO OPERATING SPECIFICATIONS. ANALYSIS OF THE POWER SUPPLY REVEALED A MALFUNCTION THAT MAY RESULT IN THE UNIT SHUTTING DOWN DURING OPERATION WITH AN ACTIVE BACKUP ALARM WHEN AC POWER IS RESTORED.

    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