BENEVISION DISTRIBUTED MONITORING SYSTEM (DMS)
Received Jun 26, 2025 · Event occurred May 23, 2025
Report 3009156722-2025-00010 · MDR key 22341744
Device
Product problems
- Device Alarm System
- Device Alarm System
Patient
NA · Unknown
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE CUSTOMER BIOMED COLLECTED SYSTEM LOGS AND SENT THEM TO MINDRAY FOR EVALUATION. IT WAS REPORTED THE PATIENT DATABASE WAS NOT PROVIDED BECAUSE THE EMERGENCY DEPARTMENT USERS DID NOT PUT THE PATIENT'S NAME INTO THE MONITOR. MINDRAY REQUESTED ADDITIONAL OCCURRENCE DETAILS TO BE ABLE TO PROCEED. UNDER INVESTIGATION.
Description of Event or Problem
IT WAS REPORTED THAT ON (B)(6) 2025, AT 14:00, THERE WAS A MISSED ALARM AT THE EMERGENCY DEPARTMENT WORKSTATION IN ROOM (B)(6). THE CUSTOMER REQUESTED LOGS TO BE REVIEWED. AN UNKNOWN ADVERSE EVENT WAS REPORTED.
Description of Event or Problem
IT WAS REPORTED THAT ON (B)(6) 2025, AT 14:00, THERE WAS A MISSED ALARM AT THE EMERGENCY DEPARTMENT WORKSTATION IN ROOM 12. THE CUSTOMER REQUESTED LOGS TO BE REVIEWED. NO PATIENT INJURY WAS REPORTED.
Additional Manufacturer Narrative
MINDRAY CONDUCTED A REVIEW OF THE BACKEND LOGS FROM THE BENEVISION CENTRAL STATION (CS) FOR ROOM 12. THE ANALYSIS CONFIRMED THAT ALARMS WERE TRIGGERED AT THE REPORTED TIME, AND THE ALARM SOUND FUNCTIONED AS INTENDED. NO NETWORK DISCONNECTION OR SYSTEM MALFUNCTION WAS OBSERVED DURING THE RELEVANT PERIOD. THE BENEVISION CS PERFORMED PER SPECIFICATION.
Additional Manufacturer Narrative
CORRECTION: ON JUNE 30, 2025, THE CUSTOMER CLARIFIED THAT NO ADVERSE EVENT WAS REPORTED WITH THIS OCCURRENCE. THE CUSTOMER BIOMED COLLECTED SYSTEM LOGS AND SENT THEM TO MINDRAY FOR EVALUATION. IT WAS REPORTED THAT THE PATIENT DATABASE WAS NOT PROVIDED BECAUSE THE EMERGENCY DEPARTMENT USERS DID NOT PUT THE PATIENT'S NAME INTO THE MONITOR; HOWEVER, ECG STRIPS WERE PROVIDED.
Description of Event or Problem
IT WAS REPORTED THAT ON (B)(6) 2025, AT 14:00, THERE WAS A MISSED ALARM AT THE EMERGENCY DEPARTMENT WORKSTATION IN ROOM (B)(6). THE CUSTOMER REQUESTED LOGS TO BE REVIEWED. NO PATIENT INJURY WAS REPORTED.