BEUDAMED
    FDA Adverse Event Death Summary report: N

    BENEVISION N1

    MDR report key: 24273871 · Received February 5, 2026

    Report

    Report Number
    3009156722-2026-00001
    Event Type
    Death
    Date Received
    February 5, 2026
    Date of Event
    January 12, 2026
    Report Date
    March 9, 2026
    Manufacturer
    SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
    Product Code
    MHX
    PMA / PMN Number
    K202405
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    MINDRAY COLLECTED AND REVIEWED LOGS FROM THE BENEVISION DMS (SERVER AND WS), THE N1 AND N17 MONITORS, AS WELL AS ECG STRIPS AND PATIENT DATABASE INFORMATION. LOGS REVEAL THAT DURING THE COMPLAINT PERIOD, THE SOFTWARE INITIATED ALL ALARM SOUNDS AS EXPECTED BASED ON THE MEASURED PHYSIOLOGICAL PARAMETERS AND THRESHOLD SETTINGS. ALARM ACTIVATION AND DEACTIVATION EVENTS CORRESPONDED APPROPRIATELY WITH AUDIO PLAYBACK EVENTS, WITH NO MISSED AUDIO PLAYBACK EVENTS IDENTIFIED. BASED ON THE LOG REVIEW, THE BENEVISION N1 MONITOR PERFORMED PER SPECIFICATIONS. MINDRAY HAS REQUESTED TO PHYSICALLY EVALUATE THE N1 BUT IS STILL AWAITING CUSTOMER APPROVAL TO DO SO. HOWEVER, CUSTOMER REPORTED THAT THE UNIT WAS SHIPPED TO A THIRD PARTY FOR EVALUATION AND NO PROBLEMS WERE FOUND.

    Additional Manufacturer Narrative · 0

    MINDRAY COLLECTED AND REVIEWED LOGS FROM THE BENEVISION DMS (SERVER AND WS), THE N1 AND N17 MONITORS, AS WELL AS ECG STRIPS AND PATIENT DATABASE INFORMATION. LOGS REVEAL THAT DURING THE COMPLAINT PERIOD, THE SOFTWARE INITIATED ALL ALARM SOUNDS AS EXPECTED BASED ON THE MEASURED PHYSIOLOGICAL PARAMETERS AND THRESHOLD SETTINGS. ALARM ACTIVATION AND DEACTIVATION EVENTS CORRESPONDED APPROPRIATELY WITH AUDIO PLAYBACK EVENTS, WITH NO MISSED AUDIO PLAYBACK EVENTS IDENTIFIED. BASED ON THE LOG REVIEW, THE BENEVISION N1 MONITOR PERFORMED PER SPECIFICATIONS. CUSTOMER REPORTED THAT THE UNIT WAS SHIPPED TO A THIRD PARTY FOR EVALUATION AND NO PROBLEMS WERE FOUND. MINDRAY PHYSICALLY EVALUATED THE N1 UNIT AND NO PROBLEMS WERE FOUND. THE UNIT PERFORMED PER SPECIFICATIONS AND GENERATED VISUAL AND AUDIBLE ALARMS AS EXPECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT FROM INTENSIVE CARE UNIT (ICU) ROOM (B)(6) WAS TRANSPORTED TO THE CT SCANNER IN RADIOLOGY USING THE BENEVISION N1 PATIENT MONITOR (N1) (SERIAL NUMBER: (B)(6) REMOVED FROM THE BENEVISION N17 HOST PATIENT MONITOR (N17) (SERIAL NUMBER: (B)(6) IN THE ICU. DURING TRANSPORT, THE N1 WAS WIRELESSLY CONNECTED TO AND COMMUNICATING WITH THE BENEVISION DMS WORKSTATION (WS) IN THE ICU. CLINICAL STAFF REPORTED THAT THE PATIENT EXPERIENCED CARDIAC EVENTS BETWEEN APPROXIMATELY 11:45 A.M. AND 12:15 P.M. WHILE THE ICU WS ANNOUNCED ALARMS DURING THIS PERIOD, THE N1 MONITOR ACCOMPANYING THE PATIENT REPORTEDLY DID NOT PRODUCE AUDIBLE ALARMS. ALL DEVICES WERE REPORTED TO BE FUNCTIONING NORMALLY PRIOR TO THE OCCURRENCE. SUBSEQUENTLY THE PATIENT EXPIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT FROM INTENSIVE CARE UNIT (ICU) ROOM (B)(6) WAS TRANSPORTED TO THE CT SCANNER IN RADIOLOGY USING THE BENEVISION N1 PATIENT MONITOR (N1) (SERIAL NUMBER: (B)(6)) REMOVED FROM THE BENEVISION N17 HOST PATIENT MONITOR (N17) (SERIAL NUMBER: (B)(6)) IN THE ICU. DURING TRANSPORT, THE N1 WAS WIRELESSLY CONNECTED TO AND COMMUNICATING WITH THE BENEVISION DMS WORKSTATION (WS) IN THE ICU. CLINICAL STAFF REPORTED THAT THE PATIENT EXPERIENCED CARDIAC EVENTS BETWEEN APPROXIMATELY 11:45 A.M. AND 12:15 P.M. WHILE THE ICU WS ANNOUNCED ALARMS DURING THIS PERIOD, THE N1 MONITOR ACCOMPANYING THE PATIENT REPORTEDLY DID NOT PRODUCE AUDIBLE ALARMS. ALL DEVICES WERE REPORTED TO BE FUNCTIONING NORMALLY PRIOR TO THE OCCURRENCE. SUBSEQUENTLY THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68000 BENEVISION N1 N1 PATIENT MONITOR MHX SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD BENEVISION N1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death