Life Scope TR MU-651RARecalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 04931921103548), received between Jul 26, 2019 and Jul 1, 2026 — classified as 1 death, 47 malfunctions.

The most frequently reported specific device problem is “Output Problem” (17 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 48 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2026Output Problem

  THE CUSTOMER REPORTED THAT THE BIOMED WAS INFORMED BY A MONITOR TECHNICIAN THAT SOMEONE AT THE FACILITY MAY KNOW THE PASSWORD AND MAY HAVE CHANGED SETTINGS THAT RESULTED IN ALARMS BEING TURNED OFF. THIS WAS DISCOVERED WHEN ILYANA, MONITOR TECHNICIAN NOTICED A WAVEFORM THAT SHOULD HAVE GENERATED AN ALARM BUT DID NOT. UPON REVIEWING THE BEDSIDE MONITOR SETTINGS, THEY FOUND THAT THE CONFIGURATION DID NOT MATCH THE SETTINGS OF THE OTHER BEDSIDE MONITORS IN THE DEPARTMENT. THE END-USER CAN ADJUST LIMITS AS NEEDED TO OPTIMIZE MONITORING OF EACH PATIENT, AS WELL AS LIMIT ALARM FATIGUE. THE LOWEST THAT THE SPO2 LOWER LIMIT CAN BE ADJUSTED IS 50. IF THERE WAS A READING OF 18% THAT WAS WITNESSED, THIS WOULD HAVE BEEN THE PATIENT'S SPO2 READING, NOT A LOWER LIMIT SETTING. THIS DESAT WOULD HAVE TRIGGERED AN ALARM, WHICH COULD HAVE BEEN SILENCED AT THE BEDSIDE OR CNS. ANOTHER POSSIBILITY IS THAT THE SPO2 LOWER LIMIT COULD HAVE BEEN SELECTED AS "OFF." IN THIS CASE, THE LOWER LIMIT SETTING WOULD BE IRRELEVANT, AND THE MONITOR WOULD NOT ALARM FOR A DESAT. THE LOGS ARE BEING COLLECT TO SEE WHAT HAPPENED. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25682242 ↗
• MalfunctionJun 24, 2026Erratic or Intermittent Display; Display or Visual Feedback Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE LEFT SIDE OF THE BEDSIDE MONITOR (BSM) SCREEN WAS BLANK AND DID NOT DISPLAY NUMERICAL VALUES. THE ISSUE OCCURRED DURING A SURGICAL CASE, AND THE SURGEON WAS UNABLE TO REBOOT THE BSM; HOWEVER, THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25608520 ↗
• DeathJun 7, 2026Output Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THEY HAD A PATIENT DEATH WHILE THEY WERE CONNECTED TO THIS MONITOR. IT APPEARS THAT THE PATIENT WAS NOT ADMITTED TO THIS BEDSIDE MONITOR (BSM) AT ALL OR AT LEAST NOT CORRECTLY. THEY HAVE NO FULL DISCLOSURE DATA AT THE CENTRAL NURSE'S STATION (CNS) OR BEDSIDE MONITOR (BSM), AND THE PATIENT NAME/ MRN IS NOT IN THE DISCHARGED PATIENTS LIST, EVEN THOUGH THERE ARE DISCHARGES FROM LONGER AGO THAN THIS INCIDENT IN THAT LIST AND THERE WAS NO PATIENT DATA GOING TO EPIC EMR.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 25422538 ↗
• MalfunctionApr 23, 2026Application Program Problem; Unintended Application Program Shut Down

  THE CUSTOMER REPORTED THAT THIS BEDSIDE MONITOR (BSM) SPONTANEOUSLY REBOOTS. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24968339 ↗
• MalfunctionDec 22, 2025Erratic or Intermittent Display; Display or Visual Feedback Problem; Erratic or Intermittent Display; Display or Visual Feedback Problem

  THE CUSTOMER REPORTED THAT WAVEFORMS ARE DISAPPEARING AND REAPPEARING ON THIS BEDSIDE MONITOR (BSM). THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23864091 ↗
• MalfunctionDec 11, 2025Device Alarm System; No Audible Alarm; Protective Measures Problem; Device Alarm System; No Audible Alarm; Protective Measures Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE BEDSIDE MONITOR (BSM) WAS NOT AUDIBLY SOUNDING ANY ALARMS DURING SETUP, BUT THE ALARMS WERE SOUNDING AT THE CENTRAL NURSE'S STATION (CNS). NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23785405 ↗
• 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 23658961 ↗
• MalfunctionSep 12, 2025Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  THE BIOMEDICAL ENGINEER (BME) WAS CALLED AFTER HOURS AND TOLD THEY WERE EXPERIENCING ST DEPRESSION ON ALL 8 PATIENTS THEY WERE MONITORING. THEY ALSO TOLD THE BME THAT THEY RECHECKED THE PATIENTS WITH A STANDALONE ECG (MORTARA 380) AND DID NOT EXPERIENCE THE ST DEPRESSION. THE BME CHECKED THE MONITORS TO SEE IF THEY COULD PULL UP THE HISTORY NOTE BUT SAW NOTHING. THE BME DID NOT HAVE A PATIENT SIMULATOR ON HAND TO CHECK UNITS. THE NEXT DAY THE CE TECH WHO WAS ON-SITE CHECKED WITH THE DEPARTMENT, AND THE DISCREPANCY WAS NO LONGER THERE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23044682 ↗
• MalfunctionSep 4, 2025Application Program Problem; Application Program Problem

  THE CUSTOMER REPORTED THAT THE BEDSIDE MONITOR WAS NO LONGER BOOTING UP PAST THE DIAGNOSTIC CHECK SCREEN. HE SAID WHEN PRESSING RETURN IT JUST GOES INTO A LOOP AND NEVER BOOTS UP. NOT IN PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22963568 ↗
• MalfunctionAug 27, 2025No Display/Image; Display or Visual Feedback Problem; No Display/Image; Display or Visual Feedback Problem

  THE CUSTOMER REPORTED THAT THIS BSM UNIT WAS NOT SHOWING ANYTHING ON THE DISPLAY. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22903532 ↗
• MalfunctionJul 15, 2025Unintended Application Program Shut Down; Unintended Application Program Shut Down

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE BEDSIDE MONITOR (BSM) WAS BOOT LOOPING WITH AN ERROR MESSAGE STATING "WATCHDOG SLEEPING." NOT IN PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22516409 ↗
• MalfunctionMar 31, 2025No Audible Alarm; Protective Measures Problem; No Audible Alarm; Protective Measures Problem

  BIOMEDICAL ENGINEER (BME) REPORTED THAT THE BEDSIDE MONITOR (BSM) IN ONE OF THE ROOMS IS NOT SHOWING ANY ARRYTHMIA RECALL WHEN THE PATIENT HAS HAD ARRHYTHMIA'S. WHEN THE BME TRIED TO TRIGGER AN ALARM BY ADJUSTING THE HEART RATE (HR) TO A LOW LIMIT, IT DID NOT TRIGGER AN ALARM, WHEN BME SET HR TO A HIGH LIMIT THERE WAS STILL NO ALARM FROM THE DEVICE. THERE WAS NO PATIENT HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21732963 ↗
• MalfunctionMay 13, 2024Unintended Application Program Shut Down; Unintended Application Program Shut Down

  THE BIOMEDICAL ENGINEER (BME) REPORTED THE BEDSIDE MONITOR (BSM) WOULD SPONTANEOUSLY SHUT DOWN INTERMITTENTLY. THEY TRIED INSERTING ANOTHER BSM-1700 INTO THIS UNIT BUT RECEIVED AN "INPUT UNIT FAILURE" ERROR MESSAGE. IT WAS NOT IN PATENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19306556 ↗
• MalfunctionApr 18, 2024Device Alarm System; No Audible Alarm; Device Alarm System; No Audible Alarm

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE SPEAKER WAS NO LONGER MAKING A SOUND FROM THE BEDSIDE MONITOR (BSM). THE VISUAL ALARM INDICATOR IN THE ROOM IS WORKING FINE BUT THE AUDIBLE ALARMS CANNOT BE HEARD. THE ALARMS FOR THE BSM ARE ALARMING AT THE CENTRAL NURSE'S STATION (CNS) AND REMOTE NETWORK STATION (RNS). THE CUSTOMER REQUESTED THE PART NUMBER BE PROVIDED, FOR THE SPEAKER TO BE REPLACED ONSITE. NOT IN PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19140886 ↗
• MalfunctionDec 27, 2023No Audible Alarm; Protective Measures Problem; No Audible Alarm; Protective Measures Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THEIR BEDSIDE MONITOR (BSM) DID NOT HAVE AN AUDIBLE ALARM BUT HAD A VISUAL ALARM. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18397576 ↗
• MalfunctionOct 25, 2023No Device Output; Unable to Obtain Readings; Output Problem; No Device Output; Unable to Obtain Readings; Output Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE BEDSIDE MONITOR (BSM) WAS NOT PROVIDING SPO2 READINGS. IT WAS NOT CLEAR IF THERE WAS AN ERROR MESSAGE TO ALERT THE USER OF THE FAILURE, AND IF THEY COULD NOT GET THE SPO2 TO WORK FROM THE START. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18008163 ↗
• MalfunctionMay 19, 2023Unintended Application Program Shut Down; Unintended Application Program Shut Down

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE BEDSIDE MONITOR (BSM) WAS FLASHING AND SPONTANEOUSLY REBOOTING. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16965626 ↗
• MalfunctionFeb 9, 2023No Display/Image; Display or Visual Feedback Problem; Application Program Problem; Output Problem; Unintended Application Program Shut Down; No Display/Image; Display or Visual Feedback Problem; Application Program Problem; Output Problem; Unintended Application Program Shut Down

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT WHEN THE UNIT POWERS ON THEY COULD ONLY SEE THE BACKLIGHT AND NOT THE ACTUAL SCREEN. THE BME DOES NOT KNOW IF THE UNIT WAS IN PAITENT USE OR NOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16345029 ↗
• MalfunctionNov 29, 2022Output Problem; Unintended Application Program Shut Down; Output Problem; Unintended Application Program Shut Down

  THE NURSE INITIALLY REPORTED THAT THERE IS A SHORT IN THE CORD AND WHEN YOU PUSH THE CORD IN THE MONITOR, IT WILL WORK. HOWEVER, ONCE YOU LET IT GO OR RELEASE THE CORD, THE MACHINE SHUTS DOWN. THEN WHEN TECH SUPPORT (TS) WAS SPEAKING TO THE CUSTOMER, IT NOTES THAT THE ECG FLATLINES, AND THE ECG CABLE AND PADS WERE REPLACED, BUT THE ISSUE PERSISTED. LATER NOTES STATED THAT INPUT UNIT WAS REPLACED WITH ANOTHER ONE, AND THE BEDSIDE MONITOR WAS ABLE TO READ THE ECG AND ISSUE WAS RESOLVED. QA INQUIRED TO CONFIRM IF ALL THESE ISSUES WERE OCCURRING ON THIS UNIT, BUT THE CUSTOMER HAS BEEN UNRESPONSIVE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15883225 ↗
• MalfunctionNov 3, 2022Power Problem; Complete Loss of Power; Power Problem; Complete Loss of Power

  THE CUSTOMER REPORTED THAT THE BSM WAS MONITORING A PATIENT AND IT RANDOMLY SHUT OFF AND WOULD NOT POWER BACK ON. THEY WERE MONITORING A PATIENT, BUT NO INJURY OR HARM OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15719235 ↗
• MalfunctionJun 8, 2022Patient Data Problem; Patient Data Problem

  THE CUSTOMER REPORTED HAVING TROUBLE SEEING THE "ART-LINE" ON THE PATIENT'S BEDSIDE MONITOR (BSM). THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14639533 ↗
• MalfunctionMay 19, 2022Application Program Problem; Unintended Application Program Shut Down; Application Program Problem; Unintended Application Program Shut Down

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THEY WERE HAVING ISSUES WITH THE UNIT INTERMITTENTLY SHUTTING DOWN. THIS WILL HAPPEN RANDOMLY, WHILE THE UNIT IS CONNECTED TO POWER VIA AC OR BATTERY. THEY STATED THAT THE PROBLEM WILL CONTINUE TO HAPPEN EVEN AFTER ATTEMPTING A PROPER REBOOT. THE UNIT WAS RETURNED FOR EVALUATION. THE REPAIR CENTER DUPLICATED THE ISSUE, AND THERE WAS PHYSICAL DAMAGE TO FRONT ENCLOSURE. THE LCD TOUCHSCREEN WAS REPLACED AND TESTED. THEN IT OPERATED TO MANUFACTURER'S SPECIFICATIONS. NOT IN PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14440880 ↗
• MalfunctionJan 20, 2022Communication or Transmission Problem; Communication or Transmission Problem

  THE CUSTOMER REPORTED THAT THE BEDSIDE MONITOR (BSM) IS HAVING INTERMITTENT COMMUNICATION LOSS (COMM LOSS). THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13311596 ↗
• MalfunctionJan 14, 2022Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  THE CUSTOMER SYSTEMS ANALYST REPORTED THAT THE CO HEMO READINGS DISPLAYED ON THE BEDSIDE MONITOR (BSM) AND SENT TO EPIC, THEIR 3RD PARTY EMR SYSTEM, DIFFER WHEN VIEWED IN EPIC. IT IS UNCLEAR WHAT IS CAUSING THIS ISSUE. CO READING IN NK AND EPIC AT 4:12 PM EST: NK CO 5.4. EPIC CO 7.7. (B)(4) JUST TRANSFERS THE DATA AND DOES NOT ALTER THE HISTORICAL DATA BEING SENT TO EPIC. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13262041 ↗
• MalfunctionJan 14, 2022Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  THE CUSTOMER SYSTEMS ANALYST REPORTED THAT THE CO HEMO READINGS DISPLAYED ON THE BEDSIDE MONITOR (BSM) AND SENT TO EPIC, THEIR 3RD PARTY EMR SYSTEM, DIFFER WHEN VIEWED IN EPIC. IT IS UNCLEAR WHAT IS CAUSING THIS ISSUE. CO READING IN NK AND EPIC AT 4:12 PM EST: NK CO 5.4. EPIC CO 7.7. HL7 JUST TRANSFERS THE DATA AND DOES NOT ALTER THE HISTORICAL DATA BEING SENT TO EPIC. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13262011 ↗