BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVITA V800

    MDR report key: 15073649 · Received July 21, 2022

    Report

    Report Number
    9611500-2022-00180
    Event Type
    Malfunction
    Date Received
    July 21, 2022
    Date of Event
    June 26, 2022
    Report Date
    February 3, 2023
    Manufacturer
    DRÄGERWERK AG & CO. KGAA
    Product Code
    QOV
    PMA / PMN Number
    EUA200143
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    BIOMEDICAL ENGINEER
    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 WAS EXAMINED ONSITE BY DRAEGER SERVICE TECHNICIAN, AND THE LOG FILE AND THE SERVICE REPORT WERE MADE AVAILABLE FOR INVESTIGATION AT THE MANUFACTURER¿S SITE. BASED ON THE LOG FILE ANALYSIS, THE REPORTED DEVICE FAILURE (1) COULD BE CONFIRMED BEGINNING AT AROUND 7 P.M. SYSTEM TIME ON THE 27TH OF JUNE 2022 CAUSING INTERMITTENT PRESSURE RELEASES OF THE PNEUMATIC SYSTEM. SUCH AN INTERNAL DEVIATION CAN BE CAUSED BY DIFFERENT REASONS. THE ROOT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION; IT WAS ONLY POSSIBLE TO NARROW IT DOWN TO A DEVIATION IN THE GAS DOSAGE OR THE RESPECTIVE SUPERVISOR FUNCTIONS. ONE POSSIBLE EXPLANATION WOULD BE THAT THE COMMUNICATION BETWEEN THE SUBSYSTEMS WAS DISTURBED ¿ BASED ON THIS ASSUMPTION AN INTERNAL WIRING HARNESS WAS REPLACED ONSITE BY SERVICE TECHNICIAN AND AFTERWARDS THE DEVICE PASSED THE TEST ACCORDING TO THE MANUFACTURER¿S SPECIFICATION WITHOUT ANY DEVIATION. AS A SAFETY FEATURE OF THE SYSTEM, THE SAFETY SOFTWARE ANALYSES AND VERIFIES PROPER FUNCTION OF THE DEVICE. IF THE SAFETY SOFTWARE DETECTS AN INTERNAL DEVIATION REGARDING THE GAS DOSAGE, PRESSURE RELEASES ARE PERFORMED IN ORDER TO PROTECT THE PATIENT FROM POTENTIALLY HAZARDOUS DEVICE OUTPUT. FURTHERMORE, THE EMERGENCY-BREATHING VALVE OPENS TO AMBIENT TO ALLOW THE PATIENT TO BREATHE SPONTANEOUSLY. AUDIBLE ALARMS WOULD BE POSTED TO ALERT THE USER OF THE PROBLEM. IF THE ¿DEVICE FAILURE (1)¿ OCCURS, THE DEVICE HAS TO BE DISCONNECTED FROM THE PATIENT WITHOUT DELAY ACCORDING TO THE INSTRUCTIONS FOR USE. IN THE CURRENT EVENT, THE DEVICE REACTED AS SPECIFIED TO A DETECTED INTERNAL DEVIATION AND POSTED A CORRESPONDING ALARM MESSAGE. THE RESULTS OF THE INVESTIGATION DID NOT REVEAL ANY NEW RISKS WHICH ARE NOT COVERED BY THE PRODUCT RISK MANAGEMENT FILE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR FAILED WHILE IN USE ON THE PATIENT AND THE ALARM "DEVICE FAILURE (1)" WAS POSTED. THERE WERE NO PATIENT HEALTH CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR FAILED WHILE IN USE ON THE PATIENT AND THE ALARM "DEVICE FAILURE (1)" WAS POSTED. THERE WERE NO PATIENT HEALTH CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1699814 EVITA V800 VENTILATORS, INTENSIVE CARE QOV DRÄGERWERK AG & CO. KGAA NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown