BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITY ACUTE CARE SYSTEM (M540)

    MDR report key: 18090476 · Received November 8, 2023

    Report

    Report Number
    1220063-2023-00040
    Event Type
    Malfunction
    Date Received
    November 8, 2023
    Date of Event
    October 9, 2023
    Report Date
    September 16, 2024
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC
    Product Code
    MHX
    UDI-DI
    04049098009799
    PMA / PMN Number
    K113798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PROVIDER NOTICED LOSS OF WAVEFORMS ON THE C700 THEN A BLANK SCREEN. THE C700 WENT INTO A RESTART, COMPLETED ITS RESTART, CONNECTED TO M540, ALL PARAMETERS CAME BACK NORMAL. NO DISCONNECT OR LOSS OF PATIENT DATA ON M540. ROOT CAUSE WAS IDENTIFIED AS PDR (PATIENT DATA REPOSITORY) DEADLOCK. THE LOGS AND DEVICE WERE ANALYZED AND FOUND THAT THE COCKPIT REBOOT WAS DUE TO A PDR (PATIENT DATA REPOSITORY) DEADLOCK. THE SPECIFIC CAUSE OF THE PDR DEADLOCK CANNOT BE DETERMINED BUT IS MORE LIKELY TO OCCUR WITH THE GEN 2 KONTRON COCKPIT USED BY THE CUSTOMER DUE TO ITS CPU. THE GEN 2 KONTRON HAS A SOFTWARE ERROR, AND THE NEWER COCKPIT MODELS HAVE REDUCED THE DEADLOCK ISSUE WITH BETTER CPU CAPABILITIES. THE COCKPIT REBOOT IS THE WORKAROUND FOR THE PDR DEADLOCK, AND THE DEVICE IS WORKING AS DESIGNED. THE REBOOT IS THE WORKAROUND OF THE ISSUE CURRENTLY FOR THIS COCKPIT. TO ELIMINATE THE ISSUE FURTHER, THE CUSTOMER CAN DECIDE TO REPLACE THE COCKPITS.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION HAS JUST STARTED; RESULTS WILL BE PROVIDED IN A FOLLOW-UP REPORT. H3 OTHER TEXT : ONGOING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE COCKPIT OF THE PATIENT MONITORING SYSTEM PERFORMED A REBOOT DURING USE. THE BEDPLACE MONITOR CONTINUED TO MONITOR THE PATIENT. NO PATIENT CONSEQUENCES WERE RESULTING FORM THE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE COCKPIT OF THE PATIENT MONITORING SYSTEM PERFORMED A REBOOT DURING USE. THE BEDPLACE MONITOR CONTINUED TO MONITOR THE PATIENT. NO PATIENT CONSEQUENCES WERE RESULTING FORM THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812963 INFINITY ACUTE CARE SYSTEM (M540) PHYSIOLOGIC MONITORING SYSTEM, SINGLE-PATIENT MHX DRAEGER MEDICAL SYSTEMS, INC NA NA 04049098009799

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NA.| NA.