BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 1162218 · Received September 16, 2008

    Report

    Report Number
    2031642-2008-00200
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    August 22, 2008
    Report Date
    August 22, 2008
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR WENT VENT INOP AND ALARMED. THE CUSTOMER REPORTED THE UNIT WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED PROBLEM, THEREFORE, THERE WAS NO PATIENT HARM OR INVOLVEMENT. THE MANUFACTURER'S SERVICE TECHNICIAN REPORTED WHEN THE VENTILATOR WAS POWERED ON, A VENT INOP MESSAGE WAS DISPLAYED, CONFIRMING WHAT THE CUSTOMER REPORTED. THE SERVICE TECHNICIAN ALSO CONFIRMED THERE WAS A DIAGNOSTIC CODE IN THE VENTILATOR LOG HISTORY THAT INDICATED THE VENTILATOR HAD PERFORMED A RESTART. THE SERVICE TECHNICIAN REPORTED THE VENTILATOR WOULD NOT PASS POWER ON SELF TEST. THE SERVICE TECHNICIAN REPLACED THE VGA CONTROLLER PCB TO CORRECT THE PROBLEM. EXTENDED SELF TESTING (EST) WAS COMPLETED AND ALL TESTS PASSED PER OPERATING SPECIFICATIONS.

    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 NA