BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEXPRO

    MDR report key: 11806520 · Received May 11, 2021

    Report

    Report Number
    11806520
    Event Type
    Malfunction
    Date Received
    May 11, 2021
    Date of Event
    March 17, 2021
    Report Date
    March 31, 2021
    Manufacturer
    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    MULTIPLE (B)(6) CAMPUSES HAVE EXPERIENCED A "LATCHING" OXYGEN SATURATION ALARM IN THEIR TELEMETRY MONITORING SYSTEM. A PATIENT'S OXYGEN SATURATION WILL DROP BELOW THE PREDETERMINED THRESHOLD AND RETURN TO NORMAL, YET THE DATA RECORDED IN THE MONITORS LOG ERRONEOUSLY READS THAT THE OXYGEN SATURATION LEVELS WERE CONSTANTLY LOW DURING THAT TIME FRAME. GE IS AWARE OF THE ISSUE AND ACTIVELY WORKING TO RESOLVE IT. CURRENTLY THERE ARE TWO TECHNIQUES FOR CLEARING A LATCHED ALARM. THE FIRST IS FOR THE CENTRALIZED TELEMETRY MONITORING UNIT (CTMU) TO DISCHARGE AND READMIT THE PATIENT, WHICH CAUSES GAPS IN THE PATIENTS DATA LOGS. THE SECOND IS FOR THE NURSES ON THE UNIT TO UNPLUG THE ADAPTER AND PLUG IT BACK IN, THIS CAN PRESENT ISSUES WITH PATIENTS IN COVID-19 ISOLATION. CURRENTLY, GE SEEMS TO THINK THE ISSUE IS RELATED TO A MASSIMO OXYGEN SATURATION ADAPTER THAT BROADCASTS THE OXYGEN SATURATION SIGNAL TO THE TELEMETRY SYSTEM. THE LATCHING ALARMS DO NOT SEEM TO IMPACT PATIENT SAFETY, BUT CREATE INCONSISTENCIES IN THE DATA RECORDED AND STORED BY THE HEALTH SYSTEM RESULTING IN AN INACCURATE REPRESENTATION OF THE PATIENTS CONDITION DURING THEIR CARE. MANUFACTURER RESPONSE FOR TELEMETRY MONITORING SYSTEM, APEX PRO (PER SITE REPORTER). GE IS AWARE OF THE ISSUE AND ACTIVELY WORKING TOWARD A RESOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705142 APEXPRO MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) MHX GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1