BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 1040769 · Received May 9, 2008

    Report

    Report Number
    2031642-2008-00106
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    April 14, 2008
    Report Date
    April 14, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VENTILATOR'S REMOTE ALARM WAS NOT WORKING. THE CUSTOMER REPORTED THE VENTILATOR WAS IN USE AND THERE WAS NO PT HARM. THE MANUFACTURER'S SERVICE TECHNICIAN VERIFIED THE CUSTOMER REPORTED PROBLEM. THE SERVICE TECHNICIAN REPORTED THE REMOTE ALARM WOULD ONLY ALARM IF SLIGHT PRESSURE WAS APPLIED TO THE REMOTE ALARM CONNECTOR. THE SERVICE TECHNICIAN REPLACED THE MAIN PCB BOARD TO CORRECT THE CUSTOMER REPORTED PROBLEM. PERFORMANCE VERIFICATION TESTING WAS COMPLETED AND ALL TESTS PASSED TO OPERATING SPECIFICATIONS. IF THE VENTILATOR'S REMOTE ALARM IS NOT FUNCTIONAL. WHEN AN AUDIBLE ALARM IS ACTIVATED ON THE VENTILATOR THE FACILITY'S REMOTE ALARM MAY NOT SOUND.

    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 UNK