BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVITA V600

    MDR report key: 14710739 · Received June 16, 2022

    Report

    Report Number
    9611500-2022-00144
    Event Type
    Malfunction
    Date Received
    June 16, 2022
    Date of Event
    May 31, 2022
    Report Date
    August 2, 2022
    Manufacturer
    DRÄGERWERK AG & CO. KGAA
    Product Code
    QOV
    PMA / PMN Number
    EUA200143
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION HAS JUST STARTED; RESULTS WILL BE PROVIDED IN A FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 0

    THE AFFECTED DEVICE, EVITA V600, WAS EXAMINED ONSITE BY DRÄGER SERVICE AND A FAULTY CIRCUIT BOARD PBA M48.3 WAS IDENTIFIED AS ROOT CAUSE OF THE DEVICE MALFUNCTION. DIE AFFECTED CIRCUIT BOARD PBA M48.3 WAS MADE AVAILABLE FOR FURTHER INVESTIGATION AT THE MANUFACTURER¿S SITE. THE HARDWARE ANALYSIS OF THE RETURNED PBA M48.3 CIRCUIT BOARD REVEALED AN OVERLOAD AT THE INPUT FOR THE 5V VOLTAGE SUPPLY DUE TO A SHORT CIRCUIT OF THE CERAMIC CAPACITOR C5. AS A RESULT, THERE WAS A COMPLETE LOSS OF FUNCTION OF THE PBA M48.3 CIRCUIT BOARD AND THE CENTRAL CONTROL, VENTILATION AND DISPLAY FUNCTIONS OF THE DEVICE. THE CAUSE OF THE SHORT CIRCUIT OF THE CERAMIC CAPACITOR C5 COULD NOT BE DETERMINED. REPLACING THE CIRCUIT BOARD PBA M48.3 REMEDIED THE ISSUE, AND THE DEVICE WAS FINALLY SUCCESSFULLY TESTED ACCORDING TO THE MANUFACTURER'S SPECIFICATIONS. IN THE EVENT OF A COMPLETE LOSS OF VENTILATOR FUNCTION, THE SAFETY VALVE AUTOMATICALLY OPENS AGAINST AMBIENT, ALLOWING THE PATIENT TO BREATHE SPONTANEOUSLY. THE AUXILIARY AUDIBLE ALARM IS ACTIVATED TO ALERT THE USER OF THE FAILURE. THIS ALARM IS SUPPLIED FROM AN INDEPENDENT POWER SOURCE AND LASTS FOR AT LEAST 2 MINUTES. IN THE CURRENT EVENT, THE DEVICE REACTED AS SPECIFIED ON THE COMPLETE LOSS OF DEVICE FUNCTION AND GENERATED THE AUXILIARY ACOUSTIC ALARM AS SPECIFIED. THE NUMBER OF SIMILAR CASES, RELATED TO THE SAME ROOT CAUSE, IS WITHIN THE EXPECTED RANGE OF THE RESPECTIVE RISK ASSESSMENT AND THUS ACCEPTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE SUDDENLY TURNED OFF AT ABOUT 2:30 A.M. ON (B)(6), 2022. THIS CAUSED A VERY HIGH-PITCHED ALARM TO SOUND. THE MACHINE WAS SET IN BIPAP MODE UNTIL THAT TIME. IT WAS REPORTED THAT THE DEVICE COULD NOT BE SWITCHED ON AFTERWARDS. THERE WAS NO PATIENT HARM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE SUDDENLY TURNED OFF AT ABOUT 2:30 A.M. ON MAY 31, 2022. THIS CAUSED A VERY HIGH-PITCHED ALARM TO SOUND. THE MACHINE WAS SET IN BIPAP MODE UNTIL THAT TIME. IT WAS REPORTED THAT THE DEVICE COULD NOT BE SWITCHED ON AFTERWARDS. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608888 EVITA V600 VENTILATORS, INTENSIVE CARE QOV DRÄGERWERK AG & CO. KGAA NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown