BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVITA 2 DURA

    MDR report key: 6010448 · Received October 7, 2016

    Report

    Report Number
    9611500-2016-00299
    Event Type
    Malfunction
    Date Received
    October 7, 2016
    Date of Event
    August 19, 2016
    Report Date
    November 3, 2016
    Manufacturer
    DRÄGERWERK AG & CO. KGAA
    Product Code
    CBK
    PMA / PMN Number
    K970165
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION WAS STARTED BUT NOT YET CONCLUDED. A FOLLOW UP REPORT WILL BE SENT AS SOON AS POSSIBLE.

    Additional Manufacturer Narrative · 1

    THE SERVICE ENGINEER ON SITE FOUND THE VALVE AIR TO BE THE ROOT CAUSE FOR THE REPORTED PROBLEM AND EXCHANGED IT. VALVE AIR AND LOGFILES WERE PROVIDED FOR THE INVESTIGATION. DURING TESTS OF THE 16 YEARS OLD VALVE AND THROUGH LOGBOOK ANALYSIS IT COULD BE CONFIRMED THAT A FAULTY VALVE CAUSED THE VENTILATOR'S RESTART. AN AUDIBLE ALARM WILL BE POSTED BY THE DEVICE AND WHEN THE WARM START OCCURS, THE DEVICE WILL BRIEFLY POWER OFF AND THEN BACK ON. THE EMERGENCY-BREATHING VALVE WOULD OPEN ALLOWING FOR SPONTANEOUS BREATHING; HOWEVER, MANUAL VENTILATION WITH AN ALTERNATE DEVICE MAY BE CONSIDERED NECESSARY. THE ERROR CODE 02.59.001 POSTED AFTER THE RESTART ALSO POINTS TOWARDS THE PNEUMATIC RESPECTIVELY THE VALVE. AN EXCHANGE OF THE AFFECTED VALVE SOLVES THE PROBLEM.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VENTILATOR PERFORMED A RESTART WHILE THE VENTILATOR WAS CONNECTED TO A PATIENT. AFTER THE RESTART, ERROR CODE (B)(4) WAS POSTED ON THE VENTILATOR SCREEN. THE VENTILATOR WAS REMOVED FROM SERVICE. NO REPORT OF PATIENT INJURY.

    Description of Event or Problem · 1

    PLEASE SEE INITIAL-REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663148 EVITA 2 DURA VENTILATORS, INTENSIVE CARE CBK DRÄGERWERK AG & CO. KGAA N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1