Life Scope VS BSM-3552Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 04931921113677), received between Jun 15, 2018 and May 19, 2026 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Output Problem” (6 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 16, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2026Electrical /Electronic Property Problem; Unexpected Shutdown

  THE CUSTOMER REPORTED THAT 3 MONITORS SHUTDOWN WHILE IN PATIENT USE AND WHEN THEY BOOTED BACK UP, THEY DISPLAYED AN ERROR. ROOMS 1 (SN (B)(6)), 6 (SN (B)(6)), AND 7 (SN (B)(6)) IN THE (B)(6) DEPARTMENT. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25216930 ↗
• MalfunctionMay 18, 2026Power Problem; Complete Loss of Power

  THE BIOMEDICAL ENGINEER (BIOMED) REPORTED THAT THIS WAS ONE OF 3 LIFE SCOPE MONITORS THAT SHUT DOWN WHILE IN PATIENT USE AND THEN GAVE A "DEVICE ERROR" MESSAGE WHEN THEY BOOTED BACK UP. ALL 3 DEVICES DROPPED OUT AT THE SAME TIME. THE OTHER 2 DEVICES WERE REPORTED IN TICKETS 300433550 AND 300433765. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25206265 ↗
• MalfunctionMay 18, 2026Power Problem; Complete Loss of Power

  THE BIOMEDICAL ENGINEER (BIOMED) REPORTED THAT THIS WAS ONE OF 3 LIFE SCOPE MONITORS THAT SHUT DOWN WHILE IN PATIENT USE AND THEN GAVE A "DEVICE ERROR" MESSAGE WHEN THEY BOOTED BACK UP. ALL 3 DEVICES DROPPED OUT AT THE SAME TIME. THE OTHER 2 DEVICES WERE REPORTED IN TICKETS (B)(4) AND (B)(4). NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25205279 ↗
• MalfunctionApr 27, 2026Application Program Problem; Unintended Application Program Shut Down

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE BEDSIDE MONITOR (BSM) SPONTANEOUSLY REBOOTED WHILE IT WAS IN PATIENT USE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24999811 ↗
• MalfunctionDec 17, 2025Signal Artifact/Noise; Signal Artifact/Noise

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THEIR CLINICAL STAFF WITNESSED THIS BEDSIDE MONITOR (BSM) HAD ARTIFACTS AND SHOWING ECG READINGS THAT WERE UNSTABLE, RESULTING IN A TACHYCARDIA ALARM. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23828485 ↗
• MalfunctionNov 24, 2025Application Program Problem; Unintended Application Program Shut Down; Application Program Problem; Unintended Application Program Shut Down

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE LIFE SCOPE MONITOR WAS IDLING ON A STANDBY SCREEN WHEN IT STARTED ALARMING AND REBOOTING, SHOWING A BLUE BLOCK MEMORY ERROR SCREEN. TECHNICAL SUPPORT (TS) TRIED TROUBLESHOOTING WITH THE BME, BUT WHEN TRYING TO LOAD THE SOFTWARE, IT GAVE A "WATCHDOG ERROR" MESSAGE BEFORE TRYING TO REBOOT. IT WOULD THEN OCCASIONALLY LOAD THE MONITORING SCREEN AND ALARM AND THEN DISPLAY THE BLUE BLOCK MEMORY ERRORS AGAIN. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23639740 ↗
• MalfunctionJul 9, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE CUSTOMER REPORTED THAT THE NON-INVASIVE BLOOD PRESSURE (NIBP) PORT WILL NOT HOLD THE HOSE ANYMORE. THE UNIT WAS NOT IN PATIENT USE AT THE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22460152 ↗
• MalfunctionJun 9, 2025Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  THE CUSTOMER REPORTED THAT THE BEDSIDE MONITOR WAS NOT PRODUCING ACCURATE SPO2 PULSE RATE READINGS AS COMPARED TO THE ECG HEART RATE READINGS. THEY DO NOT HAVE A SIMULATOR TO TEST THE UNIT. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22171421 ↗
• MalfunctionNov 4, 2024Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  THE CUSTOMER REPORTED THAT THIS BEDSIDE MONITOR (BSM-3500) IS TAKING INACCURATE ECG READINGS. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20604774 ↗
• MalfunctionMay 5, 2022Power Problem; Power Problem

  THE CUSTOMER REPORTED THAT THIS BEDSIDE MONITOR (BSM) WAS MAKING A LOUD SCREECHING NOISE AFTER WHICH THE UNIT SHUT DOWN AND REBOOT ITSELF. AT THE TIME, THE BEDSIDE WAS DISPLAYING A "PRESS F4 TO START" ERROR. NO HARM OR INJURY OCCURRED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14289137 ↗
• MalfunctionFeb 24, 2022Output Problem; Output Problem

  THE CUSTOMER REPORTED THAT THEIR BEDSIDE MONITOR (BSM) IS PRODUCING INCORRECT READINGS. THEY ALSO STATED THAT THE READINGS ARE GOING UP AND DOWN, BUT NO ALARMS ARE BEING TRIGGERED. NO HARM OR INJURY OCCURRED. THE ISSUE WAS RESOLVED WHEN THE CUSTOMER SWAPPED PROBES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13595925 ↗
• MalfunctionJan 7, 2022Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  THE CUSTOMER REPORTED THAT THEIR BEDSIDE MONITOR (BSM) IS SHOWING INCORRECT ECG READINGS. THEY CLARIFIED THAT THE BEDSIDE WAS FALSELY ALARMED FOR TACHYCARDIA, BUT WHEN THEY MOVED THE PATIENT TO ANOTHER UNIT, THEY REALIZED THAT THE PREVIOUS READING WAS INCORRECT. NO HARM OR INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13197667 ↗
• MalfunctionJan 7, 2022Output Problem; Output Problem

  THE CUSTOMER REPORTED THAT THEIR BEDSIDE MONITOR (BSM) IS SHOWING INCORRECT ECG READINGS. THEY CLARIFIED THAT THE BEDSIDE WAS FALSELY ALARMED FOR TACHYCARDIA, BUT WHEN THEY MOVED THE PATIENT TO ANOTHER UNIT, THEY REALIZED THAT THE PREVIOUS READING WAS INCORRECT. NO HARM OR INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13197665 ↗
• MalfunctionSep 20, 2021Protective Measures Problem; Protective Measures Problem

  THE CUSTOMER REPORTED THAT THE LOW SPO2 ALARM LIMIT FOR THE BEDSIDE MONITOR (BSM) WAS CONFIGURED TO ALARM WHEN IT DIPPED TO 88, BUT IT DID NOT ALARM UNTIL 80. NO HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12497441 ↗
• MalfunctionSep 20, 2021Protective Measures Problem; Protective Measures Problem

  THE CUSTOMER REPORTED THAT THEIR BEDSIDE MONITOR (BSM) ALARM WAS CONFIGURED TO ALARM AT 88, BUT DIDN'T ALARM UNTIL 80. NO HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12497422 ↗
• MalfunctionJun 9, 2021Communication or Transmission Problem; Communication or Transmission Problem

  THE CUSTOMER REPORTED THAT THE BEDSIDE MONITORS (BSMS) RECENTLY STOPPED BEING DISPLAYED AT THE CENTRAL NURSE'S STATION (CNS). ACCORDING TO THE CUSTOMER, BOTH UNITS SHOW COMM LOSS ON THE CNS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11971379 ↗
• MalfunctionJun 9, 2021Communication or Transmission Problem; Communication or Transmission Problem

  THE CUSTOMER REPORTED THAT THE BEDSIDE MONITORS (BSMS) RECENTLY STOPPED BEING DISPLAYED AT THE CENTRAL NURSE'S STATION (CNS). ACCORDING TO THE CUSTOMER, BOTH UNITS SHOW COMM LOSS ON THE CNS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11971373 ↗
• MalfunctionDec 2, 2020Erratic or Intermittent Display; Display or Visual Feedback Problem; Output Problem; Erratic or Intermittent Display; Display or Visual Feedback Problem; Output Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE BEDSIDE MONITOR (BSM) WOULD DISPLAY SPO2; AND THEN SUDDENLY STOP DISPLAYING IT, APPEARING AS IF NO CABLE WAS PLUGGED IN. THERE WERE NO ERROR MESSAGES ON THE BSM WHEN THIS OCCURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10936092 ↗
• MalfunctionJul 31, 2019Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE BEDSIDE MONITOR (BSM) DROPPED OUT OF NETWORK DURING PATIENT MONITORING ACTIVITIES. NO CONSEQUENCE OR IMPACT TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 8848957 ↗
• MalfunctionJul 31, 2019Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE BEDSIDE MONITOR (BSM) DROPPED OUT OF NETWORK DURING PATIENT MONITORING ACTIVITIES. NO CONSEQUENCE OR IMPACT TO THE PATIENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8848908 ↗
• MalfunctionJun 15, 2018Failure to Analyze Signal; Device Issue; Device Operational Issue; Device Sensing Problem; Failure to Analyze Signal; Device Issue; Device Operational Issue; Device Sensing Problem

  THE NURSE CALLED TO ASK QUESTIONS ABOUT THE BEDSIDE MONITOR (BSM) SPO2 SETTINGS. SHE REPORTED THAT ANOTHER NURSE WAS COMPLAINING THAT THE SPO2 DID NOT ALARM WHEN THE VALUE DROPPED BELOW THE PRESET.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7606224 ↗