BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 1083355 · Received July 28, 2008

    Report

    Report Number
    2031642-2008-00171
    Event Type
    Malfunction
    Date Received
    July 28, 2008
    Date of Event
    July 9, 2008
    Report Date
    July 9, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR RESTARTED WHILE IN USE ON A PT. THE CUSTOMER REPORTED THE VENTILATOR DID ALARM AND THERE WAS NO PT HARM. THE MFR'S FIELD SERVICE TECH WAS UNABLE TO DUPLICATE THE CUSTOMER REPORTED PROBLEM. THE SERVICE TECH VERIFIED A DIAGNOSTIC CODE IN THE VENTILATOR LOG HISTORY THAT INDICATED A VENTILATOR RESTART. THE SERVICE TECH REPLACED THE CPU BOARD AS A PRECAUTION. PERFORMANCE VERIFICATION TESTING 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 UNK