BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVITA V800

    MDR report key: 13025008 · Received December 17, 2021

    Report

    Report Number
    9611500-2021-00509
    Event Type
    Injury
    Date Received
    December 17, 2021
    Date of Event
    November 30, 2021
    Report Date
    June 2, 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 Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE LOGFILE OF THE AFFECTED DEVICE WAS MADE AVAILABLE FOR THE INVESTIGATION AT THE MANUFACTURER¿S SITE. BASE ON THE INVESTIGATION IT COULD BE CONFIRMED THAT THE DEVICE GENERATED SEVERAL ALARM MESSAGES REGARDING "PRESSURE MEASUREMENT INACCURATE", "AIRWAY PRESSURE HIGH", "BREATHING HOSE KINKED" AND "MINUTE VOLUME LOW" ON THE DATE OF EVENT. FURTHERMORE, THE DEVICE PERFORMED SEVERAL PNEUMATIC RELEASES WITHIN A SHORT TIME IN ORDER TO PROTECT THE PATIENT FROM A TOO HIGH AIRWAY PRESSURE. THIS CORRESPONDS WITH THE REPORTED CLICKING NOISE FROM THE VENTILATOR AND CAUSED THAT TEMPORARILY NO VENTILATION PARAMETERS WERE DISPLAYED. HOWEVER, A STOP OF VENTILATION AS IT HAD BEEN REPORTED COULD NOT BE CONFIRMED. BASED ON THE INVESTIGATION A DEVICE MALFUNCTION COULD BE EXCLUDED AND AN ISSUE WITH THE BREATHING CIRCUIT SUCH AS AN OBSTRUCTION OF THE BREATHING CIRCUIT WAS IDENTIFIED TO BE THE ROOT CAUSE OF THE EVENT. AS PER LOG FILE THE BREATHING CIRCUIT TEST WAS FAILED AT 5:42 P.M. ON THE DATE OF EVENT. AS A SAFETY FEATURE OF THE SYSTEM, THE SAFETY SOFTWARE ANALYZES AND VERIFIES PROPER FUNCTION OF THE DEVICE. IF THE SAFETY SOFTWARE DETECTS A DEVIATION CONCERNING THE AIRWAY PRESSURE, THE DEVICE POSTS AN ACCOMPANYING VISUAL AND ACOUSTICAL ALARM. TO PROTECT THE PATIENT THE VENTILATION UNIT PERFORMS A PNEUMATIC RELEASE IN CASE OF A HIGH AIRWAY PRESSURE. IN THE CURRENT EVENT, THE DEVICE REACTED AS SPECIFIED TO THE DETECTED DEVIATION AND GENERATED CORRESPONDING ALARM MESSAGES IN ORDER TO ALERT THE USER OF THE SITUATION. TESTING THE DEVICE ACCORDING TO THE MANUFACTURER¿S SPECIFICATION IS RECOMMENDED PRIOR TO NEXT USE AS A PREVENTIVE MEASURE. THE NUMBER OF SIMILAR CASES, RELATED TO THE SAME ROOT CAUSE, IS WITHIN THE EXPECTED RANGE OF THE RESPECTIVE RISK ASSESSMENT AND THUS ACCEPTED.

    Additional Manufacturer Narrative · 0

    DUE TO A TECHNICAL ISSUE WITH OUR INTERNAL EMDR SYSTEM WE SUBMITTED FOR THE FORM FDA 3500A AN INCORRECT VALUE FOR THE FIELD H3. - NOT RETURNED TO MANUFACTURER.

    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 DEVICE STOPPED VENTILATING. A LOUD CLICKING NOSE FROM THE VENTILATOR WAS PERCEIVED, BUT NO WATER WAS REPORTEDLY FOUND IN THE TUBING/FILTER. THE DEVICE HAD GENERATED AN ALARM OF "PRESSURE MEASUREMENT INACCURATE" APPROX. 5 MINUTES PRIOR TO THE EVENT. PATIENT PREVIOUSLY ASLEEP, WITHIN MINUTES OF EVENT, PATIENT BEGAN COUGHING, SHOWED SIGNS OF COLOUR CHANGE, DESATURATING - PATIENT HAD TO BE TAKEN OFF AND HAND VENTILATED. REPORTEDLY THERE WAS NOT ANY CONFIRMED HARM TO PATIENT APART FROM OXYGEN DESATURATION.

    Description of Event or Problem · 0

    IT WAS REPORTED, THAT THE DEVICE STOPPED VENTILATING. A LOUD CLICKING NOSE FROM THE VENTILATOR WAS PERCEIVED, BUT NO WATER WAS REPORTEDLY FOUND IN THE TUBING/FILTER. THE DEVICE HAD GENERATED AN ALARM OF "PRESSURE MEASUREMENT INACCURATE" APPROX. 5 MINUTES PRIOR TO THE EVENT. PATIENT PREVIOUSLY ASLEEP, WITHIN MINUTES OF EVENT, PATIENT BEGAN COUGHING, SHOWED SIGNS OF COLOUR CHANGE, DESATURATING - PATIENT HAD TO BE TAKEN OFF AND HAND VENTILATED. REPORTEDLY THERE WAS NOT ANY CONFIRMED HARM TO PATIENT APART FROM OXYGEN DESATURATION.

    Description of Event or Problem · 0

    IT WAS REPORTED, THAT THE DEVICE STOPPED VENTILATING. A LOUD CLICKING NOSE FROM THE VENTILATOR WAS PERCEIVED, BUT NO WATER WAS REPORTEDLY FOUND IN THE TUBING/FILTER. THE DEVICE HAD GENERATED AN ALARM OF "PRESSURE MEASUREMENT INACCURATE" APPROX. 5 MINUTES PRIOR TO THE EVENT. PATIENT PREVIOUSLY ASLEEP, WITHIN MINUTES OF EVENT, PATIENT BEGAN COUGHING, SHOWED SIGNS OF COLOUR CHANGE, DESATURATING - PATIENT HAD TO BE TAKEN OFF AND HAND VENTILATED. REPORTEDLY THERE WAS NOT ANY CONFIRMED HARM TO PATIENT APART FROM OXYGEN DESATURATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1929566 EVITA V800 VENTILATORS, INTENSIVE CARE QOV DRÄGERWERK AG & CO. KGAA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention