BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERSEUS A500

    MDR report key: 13449232 · Received February 4, 2022

    Report

    Report Number
    9611500-2022-00029
    Event Type
    Malfunction
    Date Received
    February 4, 2022
    Date of Event
    January 19, 2022
    Report Date
    March 24, 2022
    Manufacturer
    DRÄGERWERK AG & CO. KGAA
    Product Code
    BSZ
    UDI-DI
    04048675253600
    PMA / PMN Number
    K133886
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION WAS JUST STARTED. THE RESULT WILL BE FORWARDED IN A FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE LOGFILE ANALYSIS IT WAS POSSIBLE TO REPRODUCE THE DESCRIBED PROBLEM. A FAILURE OF THE PWM CONTROL SIGNAL (PULSE WIDTH MODULATION CONTROL SIGNAL REQUIRED FOR ACTUATION OF THE BLOWER MOTOR) FAILURE LED TO A PREVENTIVE SHUTDOWN OF THE BLOWER UNIT. THE DEVICE ALARMED TURBOVENT2 FAILURE AS SPECIFIED. THE PCB WHICH GENERATES THE PWM SIGNAL (PCB A500 BLOWER) WAS REPLACED AND RETURNED FOR INVESTIGATION, HOWEVER THE FAILURE OF THE PWM CONTROL SIGNAL COULD NOT BE REPRODUCED AND THE ROOT CAUSE THUS NOT FINALLY DETERMINED. IN CASE OF A TURBOVENT2 FAILURE AUTOMATIC VENTILATION IS NO LONGER POSSIBLE AND THE CORRESPONDING ALARM IS GIVEN. FRESH GAS DOSAGE AND MANUAL VENTILATION REMAINS AVAILABLE. AFTER REPLACEMENT OF THE PCB A500 BLOWER THE DEVICE WAS TESTED FINE ACCORDING TO MANUFACTURER'S SPECIFICATION AND RETURNED INTO USE. 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 WHILE USING THIS DEVICE FOR A PATIENT DURING SURGERY, A "TURBO VENT 2 ERROR" MESSAGE WAS DISPLAYED AND THE VENTILATION STOPPED. THE PATIENT WAS NOT HARMED BECAUSE THE DEVICE WAS QUICKLY REPLACED WITH AN ANOTHER ONE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THIS DEVICE FOR A PATIENT DURING SURGERY, A "TURBO VENT 2 ERROR" MESSAGE WAS DISPLAYED AND THE VENTILATION STOPPED. THE PATIENT WAS NOT HARMED BECAUSE THE DEVICE WAS QUICKLY REPLACED WITH AN ANOTHER ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    891026 PERSEUS A500 ANESTHESIA UNITS BSZ MK06000 04048675253600

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown