BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVITA V800

    MDR report key: 12922536 · Received December 3, 2021

    Report

    Report Number
    9611500-2021-00481
    Event Type
    Injury
    Date Received
    December 3, 2021
    Date of Event
    November 18, 2021
    Report Date
    January 21, 2022
    Manufacturer
    DRÄGERWERK AG & CO. KGAA
    Product Code
    QOV
    PMA / PMN Number
    EUA 200143
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION WAS BASED ON THE REPORTED EVENT, FURTHER EMAIL CORRESPONDENCES AND LOGFILE ANALYSIS OF THE EVITA V800 WITH THE SERIAL NO. (B)(6) AT THE MANUFACTURER SITE. IN THE FOLLOWING CORRESPONDENCE IT COULD BE CLARIFIED THAT THE PATIENT WAS IN AN OR ROOM BETWEEN 11:27 BIS 13:28 PM WHICH WAS ALSO ANALYZED VIA THE LOGFILE DOCUMENTATION. SINCE THE TIME OF THE AFFECTED DEVICE WAS NOT ADJUSTED, A TIME SHIFT OF +1H WAS DOCUMENTED HERE. AFTER RETURNING TO THE ITS, THE PATIENT WAS RECONNECTED TO THE DEVICE AT 1:28 P.M (DEVICE SYSTEM TIME) AND SEVERAL SETTINGS WERE MADE, ACCORDING TO THE LOG FILE. HOWEVER, THE DEVICE WAS NOT ACTIVATED FROM STANDBY. THAT DID NOT HAPPEN UNTIL 2:55 PM, ACCORDING TO THE LOG FILE. AFTER THAT, SEVERAL ALARM MESSAGES CONCERNING "AIRWAY PRESSURE HIGH" WERE POSTED AROUND THAT TIME. AT 7:08 PM THE DEVICE WAS SWITCHED INTO STANDBY MODE. AS PER LOG FILE A SYSTEM TEST WAS PERFORMED SUCCESSFUL ON NOVEMBER 19TH. A DEVICE MALFUNCTION OR A STOP OF THE VENTILATION COULD NOT CONFIRMED. A MISINTERPRETATION OF THE ANTI-AIR SHOWER FUNCTION, AS INITIALLY REPORTED, COULD NOT BE CONFIRMED. OBVIOUSLY, THE USER WAS NOT AWARE ABOUT THE VENTILATION WAS IN STANDBY MODE. IN CASE THAT THE VENTILATION WILL NOT STARTED BY THE USER THE DEVICE REMAINS IN STANDBY MODE. THE PATIENT WOULD NOT VENTILATED. THE TEXT ¿STANDBY PATIENT NOT VENTILATED" WOULD DISPLAYED ON THE SCREEN. THE RESULTS OF THE INVESTIGATION DID NOT REVEAL ANY NEW RISKS WHICH ARE NOT COVERED BY THE PRODUCT RISK MANAGEMENT FILE.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS RETURNED TO INTENSIVE CARE AFTER A SURGERY AND RECONNECTED TO THE DEVICE AT 13:28 (1.28 P.M.). AT 13:57 (1.57 P.M.) THE PATIENT SUFFERED A HYPOXIC CARDIORESPIRATORY ARREST.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS RETURNED TO INTENSIVE CARE AFTER A SURGERY AND RECONNECTED TO THE DEVICE AT 13:28 (1.28 P.M.). AT 13:57 (1.57 P.M.) THE PATIENT SUFFERED A HYPOXIC CARDIORESPIRATORY ARREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1823941 EVITA V800 VENTILATORS, INTENSIVE CARE QOV DRÄGERWERK AG & CO. KGAA NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown