BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 1162216 · Received September 16, 2008

    Report

    Report Number
    2031642-2008-00204
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    August 19, 2008
    Report Date
    August 19, 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
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR RESTARTED AND ALARMED WHILE IN USE ON A PATIENT. THE CUSTOMER REPORTED THERE WAS NO PATIENT HARM. THE MANUFACTURER'S SERVICE TECHNICIAN WAS UNABLE TO DUPLICATE THE CUSTOMER REPORTED PROBLEM. HOWEVER, THE SERVICE TECHNICIAN CONFIRMED A DIAGNOSTIC CODE IN LOG HISTORY THAT INDICATED A VENTILATOR RESTART. TESTING WAS PERFORMED 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 UNK