Life Scope VS BSM-3572Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 04931921113691), received between Jan 31, 2018 and Sep 9, 2026 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Output Problem” (11 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Apr 29, 2024Open, Classified

   Due to software issue the device may give false "SpO2 Probe Failure" alarm

   Z-2025-2024 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50699208 ↗
• MalfunctionJul 29, 2026False Alarm; Erratic or Intermittent Display; Output Problem

  The Biomedical Engineer (BME) reported intermittent ECG issues with the Bedside Monitor (BSM). No patient harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50068737 ↗
• MalfunctionJun 3, 2026Intermittent Communication Failure

  THE CUSTOMER REPORTED THAT THE BEDSIDE MONITOR (BSM) WAS EXPERIENCING INTERMITTENT COMMUNICATION LOSS, WHILE ADJACENT MONITORS DID NOT LOSE COMMUNICATION. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25373372 ↗
• MalfunctionJan 30, 2026Display or Visual Feedback Problem; Image Display Error/Artifact

  THE CUSTOMER REPORTED THAT THIS BEDSIDE MONITOR (BSM) WAS DISPLAYING ECG ARTIFACTS INTERMITTENTLY. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24220611 ↗
• MalfunctionNov 7, 2025Communication or Transmission Problem; Intermittent Communication Failure; Communication or Transmission Problem; Intermittent Communication Failure

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE LIFE SCOPE MONITOR WAS IN INTERMITTENT COMM LOSS. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23498360 ↗
• MalfunctionOct 21, 2025High Test Results; Output Problem; High Test Results; Output Problem

  THE CUSTOMER REPORTED THAT THE EKG VITALS ARE SPIKING ON THIS BEDSIDE MONITOR (BSM). THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23348509 ↗
• MalfunctionOct 21, 2025Signal Artifact/Noise; Output Problem; Signal Artifact/Noise; Output Problem

  THE CUSTOMER REPORTED A NOISY ECG ON THIS UNIT. THE UNIT WAS NOT IN PATIENT USE AT THE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23347881 ↗
• MalfunctionMay 29, 2025Defective Alarm; Defective Alarm

  THE CUSTOMER REPORTED THAT THIS BEDSIDE MONITOR (BSM) SEEMS TO HAVE AN INTERMITTENT ATRIAL FLUTTER THAT THEY CAN'T GET RID OF. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22105750 ↗
• MalfunctionMar 4, 2024Unintended Application Program Shut Down; Unintended Application Program Shut Down

  THE BIOMEDICAL ENGINEER (BME) REPORTED THIS BEDSIDE MONITOR (BSM) WAS SHOWING AN SD CARD FAILURE SYMBOL ON THE SCREEN AND RANDOMLY REBOOTING ITSELF. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18825707 ↗
• MalfunctionNov 16, 2023Application Program Problem; Unintended Application Program Shut Down; Application Program Problem; Unintended Application Program Shut Down

  THE NIHON KOHDEN EMPLOYEE REPORTED THAT THE BEDSIDE MONITOR (BSM) WILL BEEP LOUDLY 3 TIMES, AND THE ENTIRE SCREEN GOES BLUE WITH WHITE LETTERS. IT BOOT LOOPS WITHOUT INPUT. THIS WAS NOT IN PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18156821 ↗
• MalfunctionAug 16, 2023Erratic or Intermittent Display; Display or Visual Feedback Problem; Output Problem; No Visual Prompts/Feedback; Erratic or Intermittent Display; Display or Visual Feedback Problem; Output Problem; No Visual Prompts/Feedback

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE DISPLAYS ON THE BEDSIDE MONITOR ARE TURNING BLACK. THEY STATED THAT ALL THEIR BSM-3500S FROM THE SITE DO THIS RANDOMLY. THIS HAS BEEN HAPPENING SINCE GO LIVE. NOT ALL THE UNITS ARE HAVING THIS ISSUE AT THIS TIME. THEY STATED THAT THIS HAS BEEN HAPPENING TO ALL THEIR UNIT AT ONE TIME OR ANOTHER AND HAPPENS RANDOMLY. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17561554 ↗
• MalfunctionJul 11, 2023Unintended Application Program Shut Down; Unintended Application Program Shut Down

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THIS BEDSIDE MONITOR (BSM) WAS CONSTANTLY REBOOTING. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17302146 ↗
• MalfunctionMay 4, 2023No Device Output; Output Problem; No Device Output; Output Problem

  THE NURSE REPORTED THAT THE BEDSIDE MONITOR (BSM) DISAPPEARED WITHOUT AN ERROR MESSAGE FROM THE CENTRAL NURSE'S STATION (CNS) LOCATED IN THE EMERGENCY DEPARTMENT. THEIR SVM MONITORS WERE ALSO ONLY INTERMITTENTLY WORKING. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16873763 ↗
• MalfunctionDec 7, 2022Output Problem; Unintended Application Program Shut Down; Output Problem; Unintended Application Program Shut Down

  THE CUSTOMER REPORTED THAT THE BEDSIDE MONITOR (BSM) KEPT RANDOMLY REBOOTING. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15936888 ↗
• MalfunctionJun 2, 2022Application Program Problem; Unintended Application Program Shut Down; Application Program Problem; Unintended Application Program Shut Down

  THE NIHON KOHDEN INSTALLER REPORTED THAT THE WHILE INSTALLING THIS BEDSIDE MONITOR (BSM), IT FUNCTIONS FOR ABOUT AN HOUR WHILE CONNECTED TO THE NETWORK AND THEN EITHER TURNS OFF OR REBOOTS. THE BSM DISPLAYS A BLUE SCREEN WITH WHITE LETTERING AS WELL AS SENDS OUT AN ALARM TONE PRIOR TO THE REBOOT. THE DISPLAYED INFORMATION HAS NOT BEEN ABLE TO BE CAPTURED DUE TO THE SPEED OF THE REBOOT OR OUTAGE. NOT IN PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14576734 ↗
• MalfunctionApr 11, 2022Output Problem; Output Problem

  THE CUSTOMER REPORTED THAT THE STAFF REPORTED THAT NUMERICS ON THE BEDSIDE MONITOR (BSM) SEEM TO JUMP UP AND DOWN RANDOMLY, INTERMITTENTLY AND NOT IN TUNE WITH PATIENT'S CONDITION. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14079346 ↗
• MalfunctionMar 17, 2022Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  THE NURSE REPORTED THAT THE BEDSIDE MONITOR (BSM) MOUNTED ONTO THE WALL IN ONE OF THEIR EMERGENCY ROOMS (ER) IS HAVING TROUBLE WITH TAKING AN ACCURATE BLOOD PRESSURE. THE BLOOD PRESSURE READINGS IS OFF WHEN COMPARED TO WHAT THE NURSES ARE GETTING WITH A MANUAL BLOOD PRESSURE, EXAMPLE OF INACCURATE READINGS IS 188/100, BUT THE READING SHOULD BE 135/80. THERE WERE NO ERROR MESSAGES ON THE SCREEN OF THE BSM. THE NURSE REPORTS THAT THEY USE A NEW BLOOD PRESSURE CUFF WITH EACH PATIENT AND THAT THE ISSUE STILL OCCURS. THE DEVICE WAS MAKING A LOUD SOUND WHILE INFLATING THE BLOOD PRESSURE CUFF. NO PATIENT HARM REPORTED. NIHON KOHDEN HAS RECEIVED THE DEVICE FOR INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13792273 ↗
• MalfunctionJun 20, 2019Incorrect Measurement; Output Problem; Incorrect Measurement; Output Problem

  IT WAS REPORTED THAT THE BSM DISPLAYED INACCURATE SPO2 AND EKG READINGS WHILE ON A PATIENT. 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 8719315 ↗
• MalfunctionAug 10, 2018Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  THE NURSE REPORTED THAT THE BEDSIDE MONITOR WAS GIVING A FLUTTERING HEART RATE. THE HR WAS JUMPING FROM 140 TO OVER 200.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7772620 ↗
• MalfunctionJan 31, 2018Incorrect, Inadequate or Imprecise Result or Readings; Device Operates Differently Than Expected; Incorrect, Inadequate or Imprecise Result or Readings; Device Operates Differently Than Expected

  THE CUSTOMER REPORTED THAT WHEN USING A TG-920P CABLE THE BEDSIDE MONITOR (BSM) KEPT GETTING AN AUTO CALIBRATION THAT WAS THROWING OFF THE MEASUREMENTS AND DRIVING THEM LOWER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7232109 ↗