BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMUS

    MDR report key: 15550001 · Received October 6, 2022

    Report

    Report Number
    9611500-2022-00266
    Event Type
    Malfunction
    Date Received
    October 6, 2022
    Date of Event
    September 15, 2022
    Report Date
    December 22, 2022
    Manufacturer
    DRÄGERWERK AG & CO. KGAA
    Product Code
    BSZ
    PMA / PMN Number
    K042607
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE REPLACED PCB MOBI WAS AVAILABLE FOR INVESTIGAITON. DURING FUNCTIONAL TESTS A DRÄGER, THE REPORTED PROBLEM COULD BE REPRODUCED. A FAILURE OF THE COMA (COMMUNICATION MASTER) PROCESSOR ONBOARD THIS PCB WAS THE ROOT CAUSE FOR THE REPORTED EVENT. IT WAS FOUND THAT THE COMA-PROCESSOR PERFORMED SPORADIC RESTARTS. THESE RESTARTS PREVENTED FROM COMMUNICATION WITH THE OTHER COMPONENTS OF THE DEVICE AND LFINALLY RESULTED IN THE REPORTED ERROR MESSAGE "INTERNAL SYSTEM FAULT! DEVICE CANNOT BE USED. NOTIFY DRÄGER SERVICE". ALL ALARMS, POSSIBLE CAUSES AND REMEDIES ARE DESCRIBED IN THE INSTRUCTIONS FOR USE. REPLACEMENT OF THE PVB MOBI HAS FIXED THE PROBLEM. THE NUMBER OF SIMILAR CASES IS WITHIN THE EXPECTED RANGE OF THE RESPECTIVE RISK ASSESSMENT AND THUS ACCEPTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING ELECTIVE ORTHOPAEDIC SURGERY, SUDDEN FAILURE OF ANAESTHETIC MACHINE OCCURED. UNABLE TO OXYGENATE/VENTILATE/MODIFY MACHINE INTERFACE IN ANY WAY THEREFORE TRANSFERRED IMMEDIATELY TO ANAESTHETIC ROOM. PATIENT WAS STABLE THROUGHOUT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING ELECTIVE ORTHOPAEDIC SURGERY, SUDDEN FAILURE OF ANAESTHETIC MACHINE OCCURED. UNABLE TO OXYGENATE/VENTILATE/MODIFY MACHINE INTERFACE IN ANY WAY THEREFORE TRANSFERRED IMMEDIATELY TO ANAESTHETIC ROOM. PATIENT WAS STABLE THROUGHOUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2859574 PRIMUS ANESTHESIA UNITS BSZ DRÄGERWERK AG & CO. KGAA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown