BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 2260262 · Received September 22, 2011

    Report

    Report Number
    2031642-2011-00333
    Event Type
    Malfunction
    Date Received
    September 22, 2011
    Date of Event
    August 24, 2011
    Report Date
    August 24, 2011
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR WAS ALARMING VENT INOP. THE CUSTOMER REPORTED THE UNIT WAS NOT IN USE ON A PATIENT; THEREFORE, THERE WAS NO PATIENT HARM OR INVOLVEMENT. DURING TESTING, THE MANUFACTURER'S SERVICE TECHNICIAN REPORTED THE VENTILATOR WOULD NOT PROCEED INTO POWER ON SELF TESTING. THE SERVICE TECHNICIAN REPLACED THE VGA PCB TO CORRECT THE FINDING. APPLICABLE FINAL TESTING WAS COMPLETED AND PASSED PER OPERATING SPECIFICATIONS. ANALYSIS OF THE VGA PCB BOARD REVEALED A MALFUNCTION THAT MAY RESULT IN THE UNIT SHUTTING DOWN DURING OPERATION WITH A BACKUP ALARM ACTIVE.

    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