BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 1053220 · Received May 28, 2008

    Report

    Report Number
    2031642-2008-00118
    Event Type
    Malfunction
    Date Received
    May 28, 2008
    Date of Event
    April 30, 2008
    Report Date
    April 30, 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 ONSITE TO PERFORM PREVENTIVE MAINTENANCE, THE CUSTOMER REPORTED TO THE MFR'S SERVICE TECHNICIAN THAT THE VENTILATOR WENT VENT INOP AND ALARMED WHILE IN USE ON A PATIENT. THE CUSTOMER REPORTED THERE WAS NO PATIENT HARM. VENT INOP, WHEN IN USE, WILL STOP PROVIDING VENTILATORY SUPPORT TO THE PATIENT. THE MFR'S SERVICE TECH REPORTED WHEN THE VENTILATOR WAS STARTED IN DIAGNOSTIC MODE, IT WOULD PERFORM A RESTART AND THEN STOP AND DISPLAY VENT INOP DUE TO A FLASH PROGRAMMING ERROR, WHICH WILL OCCUR DURING STARTUP OR POST-SERVICE. THE SERVICE TECH REPLACED THE SENSOR BOARD TO CORRECT THE FINDING. EXTENDED SELF TESTING (EST) AND PERFORMANCE VERIFICATION TESTING WAS COMPLETED, AND THE VENTILATOR PASSED PER OPERATING SPECS.

    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