BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 1030664 · Received April 15, 2008

    Report

    Report Number
    2031642-2008-00094
    Event Type
    Malfunction
    Date Received
    April 15, 2008
    Date of Event
    March 26, 2008
    Report Date
    March 26, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE PERFORMING TESTING OF THE VENTRICULAR DURING SERVICE, THE MANUFACTURER'S SERVICE TECHNICIAN REPORTED THE POWER FAIL ALARM FAILED OUT OF SPECIFICATION. THE CUSTOMER DID NOT REPORT THE FINDING DURING ANY PREVIOUS USAGE. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED. THE SERVICE TECHNICIAN REPLACED THE MAIN PCB WHICH CORRECTED THE PROBLEM. EXTENDED SELF TESTING (EST) AND 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 NA