BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVITA 4

    MDR report key: 6150918 · Received December 7, 2016

    Report

    Report Number
    9611500-2016-00369
    Event Type
    Malfunction
    Date Received
    December 7, 2016
    Date of Event
    November 6, 2016
    Report Date
    December 7, 2016
    Manufacturer
    DRÄGERWERK AG & CO. KGAA
    Product Code
    CBK
    PMA / PMN Number
    K980642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE KEYBOARD OF THE AFFECTED EVITA WAS PROVIDED FOR THE INVESTIGATION. IN A VISUAL EVALUATION IT COULD BE DETERMINED THAT A DIODE ON THE PCB OF THE KEYBOARD WAS MISSING. A LOOSE CONNECTION OF THIS DIODE CAN LEAD TO THE DEVICE SWITCHING TO STANDBY ON ITS OWN AND THE OTHER OPERATING BUTTONS NOT FUNCTIONING PROPERLY. POSSIBLE ROOT CAUSES FOR THE DIODE BECOMING LOOSE COULD BE INSUFFICIENT SOLDERING JOINTS OR EXTERNAL MECHANICAL IMPACT; THE EXACT ROOT CAUSE COULD NOT BE DETERMINED THOUGH. THIS EVENT IS AN ISOLATED CASE. IN CASE THE RESPIRATOR SWITCHES TO STANDBY THE VENTILATION DISCONTINUES, THE BREATHING SYSTEM OPENS UP AND THE DEVICE GENERATES AN AUDIBLE AND VISUAL ALARM WHICH HAS TO BE ACKNOWLEDGED BY THE USER. BY REPLACING THE KEYBOARD THE DEVICE IS OPERATIONAL AGAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVITA 4 SWITCHED FROM A VENTILATION MODE TO STANDBY AND BACK ON ITS OWN. IF THE DEVICE IS IN STANDBY THE VENTILATION CAN BE SPORADICALLY INITIATED AGAIN BY PUSHING THE OPERATING BUTTONS ¿ALARM OFF¿ OR ¿ALARM RESET" ¿ IN THIS CASE THE STANDY/START BUTTON DID NOT WORK. THIS BEHAVIOR WAS OBSERVED DURING PATIENT VENTILATION. THE DEVICE WAS TAKEN OUT OF OPERATION IMMEDIATELY. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804426 EVITA 4 VENTILATORS, INTENSIVE CARE CBK DRÄGERWERK AG & CO. KGAA NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1