BeneVision Central Monitoring System (UDI 06936415972417)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 06936415972417), received between Jun 12, 2025 and Feb 25, 2026 — classified as 2 deaths, 3 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (5 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Nov 18, 2025Open, Classified

   When the Worstation of the BeneVision DMS has a specific hardware configuration, the computer may experience audio playback failure or screen freezing.

   Z-0920-2026 · Root cause: Software design · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• DeathFeb 25, 2026Device Alarm System

  NO DEVICE MALFUNCTION WAS REPORTED BY THE CUSTOMER. IT WAS REPORTED THAT BETWEEN (B)(6) 2026, AT APPROXIMATELY 23:30 AND (B)(6) 2026, AT APPROXIMATELY 01:00, A PATIENT CONNECTED TO A TM80 UNIT AND SUBSEQUENTLY CONNECTED TO A BENEVISION DISTRIBUTED MONITORING SYSTEM (DMS) WORKSTATION EXPIRED WHILE NOT CONNECTED TO ECG LEADS. DURING THIS TIME PERIOD, THE PATIENT HAD REMOVED THE ECG LEADS. AS A RESULT, A "PATIENT DISCONNECTED FROM ECG" ALARM WAS PRESENT, AND NO CARDIAC RHYTHM ALARMS WERE GENERATED. CLINICAL STAFF WERE UNABLE TO ACKNOWLEDGE/SILENCE ALARMS FROM WORKSTATION DUE TO PRIOR EVENT.

  Patient problems: Arrhythmia

  MAUDE report 24446328 ↗
• DeathFeb 25, 2026Device Alarm System

  NO DEVICE MALFUNCTION WAS REPORTED BY THE CUSTOMER. IT WAS REPORTED THAT BETWEEN (B)(6) 2026, AT APPROXIMATELY 23:30 AND (B)(6) 2026, AT APPROXIMATELY 01:00, A PATIENT CONNECTED TO A TM80 UNIT AND SUBSEQUENTLY CONNECTED TO A BENEVISION DISTRIBUTED MONITORING SYSTEM (DMS) WORKSTATION EXPIRED WHILE NOT CONNECTED TO ECG LEADS. DURING THIS TIME PERIOD, THE PATIENT HAD REMOVED THE ECG LEADS. AS A RESULT, A "PATIENT DISCONNECTED FROM ECG" ALARM WAS PRESENT, AND NO CARDIAC RHYTHM ALARMS WERE GENERATED. CLINICAL STAFF WERE UNABLE TO ACKNOWLEDGE/SILENCE ALARMS FROM WORKSTATION DUE TO PRIOR EVENT.

  Patient problems: Arrhythmia

  MAUDE report 24446326 ↗
• MalfunctionJun 12, 2025Device Alarm System; No Audible Alarm; Device Alarm System; No Audible Alarm

  IT WAS REPORTED THAT ON (B)(6) 2025, A VENTRICULAR TACHYCARDIA (V-TACH) ALARM WAS MISSED; THE SYSTEM DID NOT GENERATE AN ALARM FOR V-TACH. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22197277 ↗
• MalfunctionJun 12, 2025Device Alarm System; No Audible Alarm; Device Alarm System; No Audible Alarm

  IT WAS REPORTED THAT ON (B)(6) 2025, AT 8:35AM, THE PATIENT ON A TM80 TELEMETRY UNIT (TELE ID 55) WAS IN VENTRICULAR TACHYCARDIA (V-TACH) FOR 5 BEATS AND THE SYSTEM DID NOT GENERATE A V-TACH ALARM. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22197272 ↗
• MalfunctionJun 12, 2025Device Alarm System; No Audible Alarm; Device Alarm System; No Audible Alarm

  IT WAS REPORTED THAT ON (B)(6) 2025, AT 8:35AM, THE PATIENT ON A TM80 TELEMETRY UNIT (TELE ID 55) WAS IN VENTRICULAR TACHYCARDIA (V-TACH) FOR 5 BEATS AND THE SYSTEM DID NOT GENERATE A V-TACH ALARM. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22197267 ↗