BEUDAMED
    FDA Adverse Event Death Summary report: N

    BENEVISION DISTRIBUTED MONITORING SYSTEM (DMS)

    MDR report key: 21183840 · Received January 17, 2025

    Report

    Report Number
    3009156722-2025-00002
    Event Type
    Death
    Date Received
    January 17, 2025
    Date of Event
    December 20, 2024
    Report Date
    December 3, 2025
    Manufacturer
    SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
    Product Code
    MSX
    PMA / PMN Number
    K220058
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SYSTEM LOGS AND DATA ASSOCIATED WITH THE OCCURRENCE WERE EVALUATED, AND NO MALFUNCTION WAS CONFIRMED FOR ANY DEVICES INVOLVED IN THE REPORT. THE REPORTED WIDENED QRS COMPLEXES ARE THE REGULAR VENTRICULAR-PACED RHYTHM AT THE TIME OF THE OCCURRENCE, WHICH DIDN'T MEET THE ALARM THRESHOLDS. THE ARRHYTHMIA ALARM FUNCTION IS PERFORMED PER SPECIFICATION. CORRECTION: B3 (CORRECTING THE YEAR DATE).

    Additional Manufacturer Narrative · 0

    SYSTEM LOGS AND DATA ASSOCIATED WITH THE OCCURRENCE WERE EVALUATED, AND NO MALFUNCTION WAS CONFIRMED FOR ANY DEVICES INVOLVED IN THE REPORT. THE REPORTED WIDENED QRS COMPLEXES ARE THE REGULAR VENTRICULAR-PACED RHYTHM AT THE TIME OF THE OCCURRENCE, WHICH DIDN'T MEET THE ALARM THRESHOLDS. THE ARRHYTHMIA ALARM FUNCTION IS PERFORMED PER SPECIFICATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON DECEMBER (B)(6) 2024, APPROXIMATELY BETWEEN 11:00 AM AND 12:30 PM, IN ROOM ID A510, ON A PATIENT PLACED ON THE TM80 TELEMETRY MONITOR (ID TELE50) THE CENTRAL MONITORING UNIT (CMU) DEPARTMENT MONITOR TECHNICIAN NOTED THE PATIENT WAS IN PACED RHYTHM AT RATE 70 AT 11:00 AM. THE CMU WAS NOTIFIED BY GATEWAY STAFF THAT THE PATIENT WAS BEING RESUSCITATED. THE MONITOR TECHNICIAN NOTED THAT QRS HAD WIDENED AND THAT THERE WAS NO ALARM. THE PATIENT EXPIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2024, APPROXIMATELY BETWEEN 11:00 AM AND 12:30 PM, IN ROOM ID (B)(6), ON A PATIENT PLACED ON THE TM80 TELEMETRY MONITOR (ID TELE50) THE CENTRAL MONITORING UNIT (CMU) DEPARTMENT MONITOR TECHNICIAN NOTED THE PATIENT WAS IN PACED RHYTHM AT RATE 70 AT 11:00 AM. THE CMU WAS NOTIFIED BY GATEWAY STAFF THAT THE PATIENT WAS BEING RESUSCITATED. THE MONITOR TECHNICIAN NOTED THAT QRS HAD WIDENED AND THAT THERE WAS NO ALARM. THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1465495 BENEVISION DISTRIBUTED MONITORING SYSTEM (DMS) BENEVISION WORK STATION MSX SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD BENEVISION WORK STATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Death