Life Scope TR MU-631RARecalls & reported problems

Summary

The FDA's MAUDE database contains 169 adverse event reports that list this exact device (DI 04931921103517), received between May 12, 2016 and Sep 22, 2026 — classified as 3 deaths, 1 injury, 163 malfunctions.

The most frequently reported specific device problem is “Output Problem” (54 reports).

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 169 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  The Biomedical Engineer (BME) reported unusual arrhythmia alarms on the Bedside Monitor (BSM), which displayed HR/PR as a single parameter. Technical Support (TS) found the Sync Source in the SpO2 settings was set to ECG and changed it to SpO2, initially resolving the alarms. The issue later returned, with PR displayed and doubled. No reports of patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50855706 ↗
• MalfunctionJul 29, 2026Output Problem

  The Biomedical Engineer (BME) reported that when trying to export data it leads to a different screen that has EKG and respiratory instead of exporting the data. They stated the touch screen on the Bedside Monitor (BSM) is malfunctioning. No patient harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50069285 ↗
• MalfunctionJul 13, 2026Incorrect, Inadequate or Imprecise Result or Readings; Data Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25803488 ↗
• MalfunctionJun 15, 2026No Display/Image; Display or Visual Feedback Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE BEDSIDE MONITOR (BSM) DISPLAY WAS BLACK EVEN THOUGH THE POWER WAS ON AND THEY COULD SEE LIGHTS AND ALARMS. NOT IN PATIENT USE AND NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25505620 ↗
• MalfunctionJun 8, 2026Unintended Application Program Shut Down

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE BEDSIDE MONITOR (BSM) UNEXPECTEDLY REBOOTED ITSELF WHILE MONITORING A PATIENT. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25425747 ↗
• InjuryMay 26, 2026Unintended Movement; Device Fell

  THE PATIENT REPORTED THAT WHILE BEING MONITORED ON THE BEDSIDE MONITOR (BSM), THE DEVICE FELL ON HIS HEAD, CAUSING HEAD LACERATIONS AND A CONCUSSION. HE WAS CALLING IN TO OBTAIN THE WEIGHT OF THE DEVICE.

  Patient problems: Concussion; Head Injury; Laceration(s)

  MAUDE report 25285259 ↗
• MalfunctionMay 11, 2026Application Program Problem; Output Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT ONE OF THEIR BEDSIDE MONITORS WAS DISCHARGED AFTER WAKING UP A PATIENT. HE WANTED TO KNOW IF THERE WAS ANY REASON THAT THE BEDSIDE WOULD DISCHARGE A PATIENT ON ITS OWN. TECH SUPPORT (TS) INFORMED THEM THAT THERE SHOULD NOT BE ANY REASON FOR THE PATIENT TO GET DISCHARGED. IT IS POSSIBLE THAT IT WAS A USER ERROR AND THAT SOMEBODY HAD DISCHARGED THE PATIENT FROM THE CNS OR AT THE BEDSIDE MONITOR. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25143839 ↗
• MalfunctionMay 11, 2026Communication or Transmission Problem; Intermittent Communication Failure

  THE CUSTOMER REPORTED THAT THIS BEDSIDE MONITOR (BSM) IS GOING INTO COMMUNICATION LOSS (COMM LOSS) INTERMITTENTLY. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25143188 ↗
• MalfunctionApr 27, 2026Application Program Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT AFTER 15-30 MINS OF DOCKING A BSM-1700 INTO THE BSM-6000, THE UNIT WILL JUST CRASH AND DISPLAY A CPU ERROR, UNABLE TO EXPORT DATA ERROR ALONG WITH OTHER ERRORS HE DOES NOT REMEMBER AT THE MOMENT. NOT IN PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25009904 ↗
• MalfunctionMar 4, 2026Output Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE BEDSIDE MONITOR DISCHARGED A PATIENT ON ITS OWN AND WENT STRAIGHT INTO STANDBY MODE AND STAYED THERE. THIS WAS NOTICED BETWEEN 11:50AM - 12:50PM AT 12:45 A SIMULATOR WAS ATTACHED FOR TESTING. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24510143 ↗
• MalfunctionJan 8, 2026No Audible Alarm; Protective Measures Problem

  THE CUSTOMER REPORTED THAT THE STAFF IS CLAIMING THE UNIT DID NOT ALARM WHEN THE PATIENT HAD AN ELEVATED HEARTRATE. THE PATIENT WAS DISCHARGED FROM THE ED AND ADMITTED TO ANOTHER DEPARTMENT WHERE THEY CODED UPON ADMIT. STAFF LOOKED INTO THE EMR FOR THE PATIENT AND SAW THE ELEVATED HR OF OVER 150BPM BUT WERE UNABLE TO VERIFY IF THE ALARMS WENT OFF AT THE CENTRAL NURSE'S STATION (CNS) IN THE REVIEW DATA DUE TO THE PATIENT BEING DISCHARGED. WHEN TECH SUPPORT (TS) ASKED THE CUSTOMER IF THEY SAW AN ALARM IN THE EMR FOR THE ELEVATED HR, THEY STATED THAT THEIR EMR DOESN'T RECORD IF THERE IS AN ALARM OR NOT AND ONLY RECORDS THE VALUES TS INFORMED THE CUSTOMER THAT UNFORTUNATELY, BECAUSE THIS HAPPENED SO LONG AGO, THE DATA WILL BE MISSING FROM THE CNS. THE CUSTOMER WAS UNAWARE THAT WE COULD SEE IF A UNIT ALARMED VIA LOGS IF IT WAS WITHIN A FEW DAYS. DUE TO THE NATURE OF THE ISSUE AT HAND AND THAT IT WAS REPORTED THAT A PATIENT CODED AFTER TRANSFER, TS IS INITIATING AN ADVERSE EVENT INVESTIGATION, EVEN THOUGH THE CUSTOMER REFUSES TO CONFIRM IF THERE WAS HARM/DEATH OR NOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24016186 ↗
• MalfunctionDec 22, 2025No Display/Image; Display or Visual Feedback Problem; No Display/Image; Display or Visual Feedback Problem

  THE CUSTOMER REPORTED THAT THE BOTTOM OF THE SCREEN ON THIS BEDSIDE MONITOR (BSM) IS BLANK AND OCCASIONALLY THE WHOLE SCREEN FLASHES WHITE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23864322 ↗
• MalfunctionDec 10, 2025Loose or Intermittent Connection; Connection Problem; Loose or Intermittent Connection; Connection Problem

  THE CUSTOMER REPORTED THAT THIS BEDSIDE MONITOR (BSM) IS NOT SHOWING UP IN THE CENTRAL NURSE'S STATION (CNS). THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23768871 ↗
• MalfunctionOct 28, 2025Output Problem; Output Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THEY WERE GETTING EXCESSIVE ARTIFACT ON A PATIENT BEING MONITORED USING A 12-LEAD CONFIGURATION COMPARED TO A 5-LEAD. THE PATIENT HAS ALREADY BEEN DISCHARGED. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23409012 ↗
• MalfunctionOct 15, 2025Output Problem; Output Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE BEDSIDE MONITOR WAS NOT BEING DISPLAYED ON THE CENTRAL NURSE'S STATION (CNS). IT IS UNCLEAR WHETHER THEY WERE UNABLE TO MONITOR FROM THE BEGINNING OR IF IT DROPPED OFF. THE CUSTOMER DID NOT KNOW. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23286627 ↗
• MalfunctionSep 29, 2025Application Program Problem; Unintended Application Program Shut Down; Application Program Problem; Unintended Application Program Shut Down

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE BEDSIDE MONITOR (BSM) WAS TURNING ON AND GOING STRAIGHT TO DEEP SETTINGS. WHEN HE TRIES TO GO OUT OF IT, IT GIVES "FATAL ERROR, SYSTEM WILL RESTART" MESSAGE AND JUST RESTARTS AND LOOPS BACK TO THE DEEP SETTINGS. NOT IN USE WITH A PATIENT, NO PATIENT HARM, FOUND DURING SETUP. NOT IN PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23175797 ↗
• MalfunctionSep 25, 2025No Audible Alarm; Protective Measures Problem; No Audible Alarm; Protective Measures Problem

  THE CUSTOMER REPORTED THAT THE MONITOR AT THE CENTRAL NURSE'S STATION (CNS) WILL NOT ALARM WHEN THE HEART RATE IS ABOVE 120. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23143550 ↗
• MalfunctionSep 23, 2025Application Program Problem; Unintended Application Program Shut Down; Application Program Problem; Unintended Application Program Shut Down

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THEY HAVE HAD COMPLAINTS FROM THE ER ON THIS MONITOR FOR THE LAST TWO WEEKS. STAFF COMPLAINED THAT THE UNIT REBOOTS, WE BLOCKED THE ROOM AND ATTACHED SIMULATOR AT LET IT RUN FOR THREE HOURS WITH NO ISSUES. NEXT TIME THE STAFFED COMPLAINED, THE BME REMOVED THE MONITOR AND BROUGHT IT TO THE SHOP, HOOKED UP A SIMULATOR AT LET UNIT RUN FOR 24 HOURS WITH NO ISSUES. BOTH TIMES THEY RETURNED TO ER. ON (B)(6) 2025, STAFF COMPLAINED AGAIN ABOUT THE UNIT TURNING OFF. THE BME WENT TO THE ROOM AND DISCOVERED THAT THE UNIT REBOOTS. WHEN IT COMES ON, IT PRODUCES A SCREEN FULL OF INFORMATION, THEN REBOOTS. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23129252 ↗
• MalfunctionSep 10, 2025Delayed Alarm; Device Alarm System; Protective Measures Problem; Delayed Alarm; Device Alarm System; Protective Measures Problem

  THE CUSTOMER REPORTED THAT THE ALARMS ARE NOT SOUNDING WHEN EXPECTED, AND THE SCREEN HAS A BANNER READING: "ALARM SUSPENDED." THIS HAPPENS AFTER SUSPENDING AN ALARM. IT TAKES 30 SECONDS LONGER THAN THE SET TIME TO RESUME MONITORING AND ALARMING. THEY ALSO FELT THAT IF A PATIENT'S HEART RATE REACHED 190, IT SHOULD NOT JUST ALARM FOR WARNING. TECH SUPPORT STATED THAT IT IS POSSIBLE WITH EXTENDED ARRHYTHMIA SETTINGS TO ALARM DIFFERENTLY. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23022798 ↗
• MalfunctionSep 2, 2025No Display/Image; Display or Visual Feedback Problem; Output Problem; No Display/Image; Display or Visual Feedback Problem; Output Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE SCREEN TURNED WHITE WHILE IN PATIENT USE. WHEN THE BME ARRIVED, THE MONITOR WAS OFF AND NOT CONNECTED TO THE PATIENT. THEY TURNED THE MONITOR ON AND FOUND THE ISSUE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22947347 ↗
• MalfunctionAug 27, 2025False Alarm; Display Difficult to Read; Display or Visual Feedback Problem; False Alarm; Display Difficult to Read; Display or Visual Feedback Problem

  THE CUSTOMER REPORTED THAT WHEN THEY PRESS THE "NIBP START" BUTTON ON THIS UNIT, A BUNCH OF BLUE BOXES WITH WHITE TEXT APPEAR AND THE UNIT GOES INTO CRITICAL ALARM. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22903195 ↗
• MalfunctionAug 7, 2025No Display/Image; Display or Visual Feedback Problem; Output Problem; No Display/Image; Display or Visual Feedback Problem; Output Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT WHEN POWERING ON THE BEDSIDE MONITOR (BSM), THE BOTTOM HALF OF THE SCREEN WAS ALL WHITE. THEY TRIED REBOOTING THE DEVICE, BUT THE ISSUE PERSISTED. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22739230 ↗
• MalfunctionJun 20, 2025Display Difficult to Read; Display or Visual Feedback Problem; Display Difficult to Read; Display or Visual Feedback Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE BEDSIDE MONITOR (BSM) HAD A WHITE DISPLAY SCREEN WITH LINES ALL OVER IT. THE DEVICE WAS ON AN ARM AND WAS NOT ACCESSIBLE TO ANYONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22302422 ↗
• MalfunctionApr 29, 2025Display or Visual Feedback Problem; Output Problem; No Visual Prompts/Feedback; Display or Visual Feedback Problem; Output Problem; No Visual Prompts/Feedback

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE BEDSIDE MONITOR (BSM) WENT BLANK WHILE THEY WERE WORKING ON A PATIENT IN ER. THERE WAS AN RTS ERROR MESSAGE ON THEIR BSM-6301A DURING BOOT-UP, ALONG WITH TOUCHSCREEN ISSUES WHERE ONLY HALF OF THE MONITOR WAS WORKING. THE BSM-6301A WOULD NOT BOOT UP NORMALLY. UPON STARTUP, THE SCREEN GOES BLANK, DISPLAYS A FAULT ERROR, AND ALL VALUES DEFAULT TO ZERO. THE TRANSPORT MODULE - THE BSM-1700 CONNECTED TO THE BSM-6301A WAS REMOVED AND DOCKED TO ANOTHER BEDSIDE MONITOR TO CONTINUE MONITORING THE PATIENT. THE CUSTOMER DOES NOT KNOW WHAT BSM-1700 MODEL WAS BEING USED WITH THE BSM-6301A. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21931407 ↗
• MalfunctionApr 11, 2025No Device Output; Output Problem; No Device Output; Output Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE BSM-6301A BEDSIDE MONITOR WAS NOT DISPLAYING THE RHYTHM OF THE ECG. ANOTHER BSM-6301A BEDSIDE MONITOR WAS BROUGHT INTO THE ROOM TO MONITOR THE PATIENT AND TO CONTINUE ON THE CASE. THE BME STATED THAT NO MATTER WHAT BSM-1700 THEY CONNECT TO THE BSM-6301A BEDSIDE MONITOR, THE ISSUE FOLLOWS THE BSM-6301A BEDSIDE MONITOR. THERE WERE NO ERROR MESSAGE WHEN THE ECG RHYTHM STOPPED DISPLAYING. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21831433 ↗