Life Scope TR MU-671RA (UDI 04931921103562)Recalls & reported problems

Summary

The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 04931921103562), received between May 13, 2016 and Aug 14, 2026 — classified as 68 malfunctions.

The most frequently reported specific device problem is “Output Problem” (25 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 69 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2026No Audible Alarm; Protective Measures Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50257231 ↗
• MalfunctionAug 12, 2026Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50221407 ↗
• MalfunctionJun 8, 2026Output Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE VITALS DISAPPEAR WHILE MONITORING ON THIS BEDSIDE MONITOR (BSM). THIS UNIT WILL RANDOMLY DROP OUT ITS WAVEFORMS AND THEN IT WILL COME BACK A FEW MINUTES LATER. WHEN WAVEFORM DROPS OUT, ITS MATCHING NUMERICAL VALUE ALSO DISAPPEARS AND THEN REAPPEARS WHEN THE WAVEFORM RETURNS. CUSTOMER SPECIFICALLY CALLED OUT SEEING THIS BEHAVIOR ON ECG AND SPO2, WHERE NIBP WOULD REMAIN IN ITS POSITION, NOT SHIFTING TO THE PRIMARY SLOT, BUT ECG AND SPO2 WOULD DISAPPEAR FOR A FEW MINUTES BEFORE RETURNING. THIS BEHAVIOR STARTS WITHIN THE FIRST MINUTE OR TWO OF OPERATION. THIS IS A STANDALONE UNIT AND IS NOT MONITORED BY A CENTRAL NURSE'S STATION (CNS) OR REMOTE NETWORK STATION (RNS).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25428470 ↗
• MalfunctionMay 11, 2026Power Problem; Complete Loss of Power

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE BEDSIDE MONITOR (BSM) SHUT DOWN WHILE MONITORING A PATIENT. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25135652 ↗
• MalfunctionApr 23, 2026No Display/Image; Display or Visual Feedback Problem; Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  THE CUSTOMER REPORTED THAT THIS BEDSIDE MONITOR (BSM) IS NOT DISPLAYING THE A LINE WAVEFORM. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24966111 ↗
• MalfunctionApr 13, 2026Output Problem

  THE NURSE REPORTED THAT WHILE THE BIS IS CONNECTED TO THE BEDSIDE MONITOR, IT IS NOT DISPLAYING A NUMERIC VALUE ON THE BIS, AND THE WAVEFORM INTERMITTENTLY DISAPPEARS. THEY STATED THEY HAD ALREADY SWAPPED OUT BOTH THE BIS MODULE AND THE CONNECTING CABLE, BUT THE ISSUE PERSISTS. THE SETUP INCLUDES A DAU CONNECTED TO A BSM-6000. TECH SUPPORT (TS) ADVISED THAT SINCE REPLACING THE BIS AND CABLE DID NOT RESOLVE THE ISSUE, FURTHER TROUBLESHOOTING WOULD BE REQUIRED BY BIOMED. RECOMMENDED CHECKING OR SWAPPING THE DAU, BSM, OR TRANSPORT UNIT. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24867315 ↗
• MalfunctionApr 7, 2026Application Program Problem; Unintended Application Program Shut Down

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THEY ARE GETTING BLUE LINES ON THE SCREEN AND IT WOULD REBOOT. HE WAS TRYING TO PULL THE SETTINGS FROM THE MONITOR DUE TO THE UNIT REBOOTING. HE STATED THAT CURRENTLY THE MONITOR IS BOOTING UP INTO THE DEEP SETTINGS. HE STATED THAT HE IS GETTING A FATAL ERROR. "WATCHDOG IS SLEEPING." NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24811409 ↗
• MalfunctionFeb 19, 2026Display or Visual Feedback Problem

  THE CUSTOMER REPORTED THAT THIS BEDSIDE MONITOR IS HAVING ISSUES WITH REPEATEDLY PICKING UP A DUPLICATE BED-ID WITH A TRANSPORT MONITOR. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24389993 ↗
• MalfunctionFeb 19, 2026Display or Visual Feedback Problem

  THE CUSTOMER REPORTED THAT THIS BEDSIDE MONITOR IS HAVING ISSUES WITH REPEATEDLY PICKING UP A DUPLICATE BED-ID WITH A TRANSPORT MONITOR. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24389909 ↗
• MalfunctionFeb 11, 2026Gas Output Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE BEDSIDE MONITOR (BSM) WAS DROPPING CO2 READINGS DURING PATIENT USE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24313487 ↗
• MalfunctionJan 5, 2026No Audible Alarm

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE BEDSIDE MONITOR (BSM) WAS NOT AUDIBLY ALARMING. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23956728 ↗
• MalfunctionDec 19, 2025Pumping Problem; Pumping Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE BEDSIDE MONITOR (BSM) NON-INVASIVE BLOOD PRESSURE (NIBP) PUMP WOULD INTERMITTENTLY WORK. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23850677 ↗
• MalfunctionNov 26, 2025Unintended Application Program Shut Down; Unintended Application Program Shut Down

  THE BIOMEDICAL ENGINEER (BME) REPORTED ON (B)(6) 2025 THAT THIS BEDSIDE MONITOR (BSM) WAS RANDOMLY REBOOTING. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23658960 ↗
• MalfunctionNov 26, 2025Unintended Application Program Shut Down; Unintended Application Program Shut Down

  THE BIOMEDICAL ENGINEER (BME) REPORTED ON 11/04/2025 THAT THIS BSM WAS RANDOMLY REBOOTING. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23658623 ↗
• MalfunctionNov 25, 2025Computer Software Problem; Computer Software Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE BEDSIDE MONITOR (BSM) BEHAVED AS IF THERE WAS A LOOP BACK/WATCHDOG ERROR. THE BSM WAS REPLACED, AND THE SAME SYMPTOMS CONTINUE WITH THE NEW BSM. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23648810 ↗
• MalfunctionNov 14, 2025Unintended Application Program Shut Down; Unintended Application Program Shut Down

  THE BIOMEDICAL ENGINEER (BME) REPORTED TO NIHON KOHDEN ON 10/17/2025 THAT THE BEDSIDE MONITOR (BSM) RANDOMLY REBOOTED AROUND 12:31 ON 10/12/2025. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23560448 ↗
• MalfunctionNov 12, 2025Output Problem; Output Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE BEDSIDE MONITOR (BSM) IS DISPLAYING VITALS ON SCREEN WITHOUT ISSUE. INTERMITTENTLY, THE WAVE FOR ALL PARAMETERS WILL RESET AND THE WAVE WILL START OVER FROM THE LEFT SIDE OF THE SCREEN. AT THE CENTRAL NURSE'S STATION (CNS) THE WAVES DO NOT SEEM TO HAVE ANY ISSUES. ALSO FULL DISCLOSURE AT BOTH THE BSM AND CNS DO NOT SHOW ANY SIGNS OF THIS ISSUE. THEY REBOOTED BSM-6000. THEY SWAPPED LEAD AND CABLES. BSM-1700 ATTACHED TO IT AS A STAND ALONE DID NOT SEEM TO DISPLAY THIS ISSUE. THEY REDOCKED THE BSM-1700 INTO THE BSM-6000. THEY DID THOSE TROUBLESHOOTING STEPS BUT THE ISSUE PERSISTS, SO TECH SUPPORT (TS) ADVISED TO SWAP THE BSM-6000 OUT FOR THE TIME BEING SO ADDITIONAL TROUBLESHOOTING COULD BE DONE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23537668 ↗
• MalfunctionOct 29, 2025Unintended Application Program Shut Down; Unintended Application Program Shut Down

  THE BIOMEDICAL ENGINEER (BME) RECEIVED REPORTS THAT THE BEDSIDE MONITOR (BSM) WAS RANDOMLY REBOOTING. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23414173 ↗
• MalfunctionAug 6, 2025Display Difficult to Read; Display or Visual Feedback Problem; Output Problem; Display Difficult to Read; Display or Visual Feedback Problem; Output Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE BEDSIDE MONITOR (BSM) MU-671RA IS FLASHING RAPIDLY WITH LINES APPEARING ON THE DISPLAY. THE ISSUE WAS OBSERVED DURING PATIENT USE, IN THE MIDDLE OF A CASE. THEY IMMEDIATELY BROUGHT IN ANOTHER MONITOR SO THE STAFF COULD CONTINUE, AND PATIENT VITALS WERE MONITORED VIA THE TRANSPORT MODULE DURING THE DOWNTIME. THEY ATTEMPTED TO SWAP OUT THE ECG LEADS AND TRUNK CABLE TO ADDRESS THE INTERFERENCE ON THE DISPLAY, BUT THIS DID NOT RESOLVE THE ISSUE. HE ALSO REPLACED THE TRANSPORT MODULE, BUT THE DISPLAY CONTINUED TO FLASH RAPIDLY. HE ALSO NOTED THAT THE SAWTOOTH WAVEFORM APPEARS TO BE CONSTANT. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22734244 ↗
• MalfunctionJun 17, 2025Device Alarm System; No Audible Alarm; Device Alarm System; No Audible Alarm

  THE CUSTOMER REPORTED THAT THIS UNIT FAILED TO ALARM FOR ARRHYTHMIA. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22233151 ↗
• MalfunctionJun 5, 2025Display or Visual Feedback Problem; Unintended Application Program Shut Down; Display or Visual Feedback Problem; Unintended Application Program Shut Down

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE BEDSIDE MONITOR (BSM) WOULD BEEP THREE TIMES, GIVE AN ERROR MESSAGE, AND THEN SHUT DOWN. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22155089 ↗
• MalfunctionMar 12, 2025Unintended Application Program Shut Down; Unintended Application Program Shut Down

  THE CUSTOMER EMAILED TO REPORT THAT THEIR BEDSIDE MONITOR (BSM) WOULD SHUT DOWN WHILE IN PATIENT USE AND DISPLAY MULTIPLE ERRORS BEFORE BOOTING BACK ON AGAIN. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21583544 ↗
• MalfunctionJul 2, 2024No 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 BSM HAD A BLANK SCREEN WHILE IN USE. THEY CAN POWER ON THE DEVICE BUT CANNOT SEE ANYTHING ON THE SCREEN. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19662275 ↗
• MalfunctionSep 22, 2023Output Problem; Output Problem

  THE BIOMEDICAL ENGINEER REPORTED THAT 2 BEDSIDE MONITORS IN THE ROOMS WERE SHOWING THE INCORRECT PATIENT INFORMATION AND INCORRECT INFORMATION AT THE CENTRAL NURSE'S STATION (CNS) AS WELL. THE PATIENT NAMES AND VITALS WERE SWAPPED. THIS ONLY HAPPENED ON 2 BEDS AT THIS TIME. THE STAFF ALREADY RESOLVED THIS ISSUE BY DISCHARGING AND READMITTING THE PATIENTS. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17801301 ↗
• MalfunctionJun 15, 2023Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE THE BEDSIDE MONITOR (BSM) STOPPED SHOWING ECG DATA WHILE IN PATIENT USE. NO REPORTS OF PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17140701 ↗