Life Scope VS BSM-3532Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 04931921113660), received between Jul 10, 2020 and Sep 25, 2026 — classified as 3 deaths, 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• DeathSep 25, 2026Device Alarm System; Protective Measures Problem

  The Biomedical Engineer (BME) reported a patient event involving a death while the patient was connected to the Bedside Monitor (BSM). The BME requested a review of the device logs to determine whether the monitor alarmed appropriately and whether a staff member silenced the alarm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897036 ↗
• MalfunctionApr 17, 2026Application Program Problem; Unintended Application Program Shut Down

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE BEDSIDE MONITORS ARE RANDOMLY POWERING OFF. THEY HAVE TO REBOOT THE MONITOR TO POWER THEM ON. THE STATED THE UNIT DID NOT HAVE ANY LIGHTS WHILE IT WAS POWERED OFF. THEY DO NOT HAVE A BATTERY. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24918128 ↗
• MalfunctionMar 16, 2026No Display/Image; Display or Visual Feedback Problem

  THE CUSTOMER REPORTED THAT THIS BEDSIDE MONITOR (BSM) WAS NOT PROVIDING THE ECG OR SPO2 READINGS UNTIL THEY REBOOTED THE UNIT. THE UNIT WAS NOT IN PATIENT USE AT THE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24603947 ↗
• MalfunctionFeb 27, 2026Display or Visual Feedback Problem; Image Display Error/Artifact

  THE CUSTOMER REPORTED THAT THE ECG WAVEFORMS ARE ABNORMAL LOOKING. THE ISSUE WAS DISCOVERED DURING SETUP. THE UNIT WAS NOT IN PATIENT USE AT THE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24471221 ↗
• MalfunctionOct 24, 2025Unable to Obtain Readings; Output Problem; Unable to Obtain Readings; Output Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE BEDSIDE MONITOR (BSM) WAS EXPERIENCING WAVEFORM DROPOUTS. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23383291 ↗
• MalfunctionOct 8, 2025No Display/Image; Key or Button Unresponsive/not Working; No Display/Image; Key or Button Unresponsive/not Working

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE BEDSIDE MONITOR (BSM) HAD A BLACK SCREEN WITH A SOLID BLUE ALARM INDICATOR LIGHT. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23248194 ↗
• MalfunctionMay 27, 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 (BSM) HAD WAVEFORM DROPOUTS. THEY TRIED TESTING THE DEVICE ON A SIMULATOR BUT COULD NOT DUPLICATE THE ISSUE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22092703 ↗
• MalfunctionApr 4, 2025Application Program Problem; Unintended Application Program Shut Down; Application Program Problem; Unintended Application Program Shut Down

  THE NURSE REPORTED THAT THE DEVICE REBOOTED ON ITS OWN AND THAT A BLUE SCREEN POPPED UP, DISPLAYING LINES OF BINARY NUMBERS. THE DEVICE IS NOT ON THE NETWORK, SO IT COULD NOT BE A NETWORK LOOP. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21780803 ↗
• MalfunctionJan 31, 2025Signal Artifact/Noise; Output Problem; Signal Artifact/Noise; Output Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE BEDSIDE MONITOR (BSM) HAD INTERMITTENT ECG INTERFERENCE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21289273 ↗
• MalfunctionJan 14, 2025Application Program Problem; Application Program Freezes or Fails to Launch; Unintended Application Program Shut Down; Application Program Problem; Application Program Freezes or Fails to Launch; Unintended Application Program Shut Down

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE BEDSIDE MONITOR (BSM) WILL NOT POWER OFF WHEN THE POWER BUTTON WAS HELD. ALSO, THE BSM WAS REPORTED TO BE POWERING OFF AND ON FOR NO REASON WHILE IN PATIENT USE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21154426 ↗
• MalfunctionJun 5, 2023Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER REPORTED THAT THE BEDSIDE MONITOR (BSM) IS SPONTANEOUSLY SHUTTING DOWN. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17060457 ↗
• MalfunctionMay 24, 2023No Device Output; Output Problem; No Device Output; Output Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE ECG WILL SHOW FOR A LITTLE WHILE, BUT THEN IT WILL RANDOMLY STOP SHOWING ANYTHING AT ALL ON THIS BEDSIDE MONITOR (BSM). THERE ARE NO ERROR MESSAGES WHEN THIS OCCURS. THEY HAVE SWAPPED OUT LEAD SETS, BUT THE ONLY WAY TO FIX IT IS TO REBOOT THE BSM. HOWEVER, EVEN AFTER THAT, IT WORKS FOR A LITTLE WHILE BEFORE IT STOPS WORKING AGAIN. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16998207 ↗
• MalfunctionMar 31, 2023Output Problem; Output Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE SPO2 IS INTERMITTENTLY WORKING, AND THEY ARE ABLE TO SEE THAT ON THE BEDSIDE MONITOR THAT THE PROBE IS NO LONGER CONNECTED. THE SCREEN BLANKS OUT, AND THERE IS NO ERROR MESSAGE DISPLAYED. HE HAS STATED THAT THIS HAS OCCURRED WITH VARIOUS DIFFERENT CABLES. HE HAS ALSO TRIED ATTACHING DIFFERENT PROBES TO SEE IF THE PROBES WERE THE ISSUE, AND THEY WERE NOT. HE HAS TESTED ON MULTIPLE DIFFERENT BSM-3532. THEY STATED THAT THE CABLING SEEMS TO BE THE ISSUE WITH THE CONNECTION RATHER THAN THE PROBE. NOT IN PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16660500 ↗
• MalfunctionDec 28, 2022Mechanical Problem; Detachment of Device or Device Component; Device Fell; Mechanical Problem; Detachment of Device or Device Component; Device Fell

  THE CUSTOMER REPORTED THAT THE BEDSIDE MONITOR (BSM) FELL FROM THE WALL MOUNT IT WAS ATTACHED TO. THE MOUNT WAS NOT CORRECTLY MOUNTED INTO THE WALL STUDS, AND THE DEVICE FELL FROM ABOUT 5 FEET UP. NO HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16065194 ↗
• MalfunctionNov 18, 2022Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  THE CUSTOMER REPORTED THAT THE NIBP MODULE FOR THE BEDSIDE MONITOR (BSM) WAS INTERMITTENTLY PRODUCING INCORRECT BP READINGS. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15823114 ↗
• MalfunctionApr 6, 2022Communication or Transmission Problem; Communication or Transmission Problem

  THE CUSTOMER REPORTED THAT THE BEDSIDE MONITOR (BSM) SHOWS IN COMMUNICATION LOSS (COMM LOSS) ON THE CENTRAL NURSE'S STATION (CNS).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14031769 ↗
• MalfunctionMar 20, 2022Mechanical Problem; Mechanical Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE UNIT WILL INFLATE THE CUFF CORRECT PRESSURE, BUT DURING THE DEFLATION PORTION THE PUMP DOES NOT DO ANYTHING AND DOES NOT DEFLATE THE CUFF. TECH SUPPORT (TS) ASKED THE CUSTOMER IF THE UNIT GIVE A "MODULE FAILURE" MESSAGE, AND THE CUSTOMER STATED THAT "NO. IT JUST SITS THERE NOT DOING ANYTHING." NOT IN PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13831609 ↗
• MalfunctionJan 14, 2022Communication or Transmission Problem; Communication or Transmission Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE BEDSIDE MONITOR (BSM) STARTED FLASHING RED AND THEN IT REBOOTED ITSELF WHILE MONITORING A PATIENT. THE BME STATED THAT THEY DID A FEW TESTS WITH THE BEDSIDE AND IT SEEMS TO BE WORKING BUT THEY WANT TO SEND IT IN FOR INSPECTION AS A PRECAUTION. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13261986 ↗
• MalfunctionJan 14, 2022Application Program Problem; Communication or Transmission Problem; Application Program Problem; Communication or Transmission Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE BEDSIDE MONITOR (BSM) STARTED FLASHING RED AND THEN IT REBOOTED ITSELF WHILE MONITORING A PATIENT. THE BME STATED THAT THEY DID A FEW TESTS WITH THE BEDSIDE AND IT SEEMS TO BE WORKING BUT THEY WANT TO SEND IT IN FOR INSPECTION AS A PRECAUTION. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13261960 ↗
• DeathJan 5, 2022Protective Measures Problem; Protective Measures Problem

  THE CUSTOMER REPORTED THAT ONE OF THEIR PATIENTS EXPERIENCED A FATAL RHYTHM THAT THE BEDSIDE MONITOR (BSM) DID NOT PICK UP. THE ECG PRINT OUT SUGGEST A FASTER RATE WITHOUT A DOCUMENTED CRISIS ALARM. THE DOCUMENTATION ALSO REVEALS A LOW MV FOR THE PATIENT HR. HOWEVER, ARRHYTHMIA ALARMS DID CAPTURE AN "IRREGULAR RR".

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

  MAUDE report 13170656 ↗
• DeathJan 5, 2022Protective Measures Problem; Protective Measures Problem

  THE CUSTOMER REPORTED THAT ONE OF THEIR PATIENTS EXPERIENCED A FATAL RHYTHM THAT THE BEDSIDE MONITOR (BSM) DID NOT PICK UP. THE ECG PRINT OUT SUGGEST A FASTER RATE WITHOUT A DOCUMENTED CRISIS ALARM. THE DOCUMENTATION ALSO REVEALS A LOW MV FOR THE PATIENT HR. HOWEVER, ARRHYTHMIA ALARMS DID CAPTURE AN "IRREGULAR RR".

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

  MAUDE report 13170621 ↗
• MalfunctionAug 16, 2021Communication or Transmission Problem; Communication or Transmission Problem

  THE CUSTOMER REPORTED THAT THEY'RE GETTING COMMUNICATION LOSS ON THIS BEDSIDE MONITOR. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12328862 ↗
• MalfunctionAug 16, 2021Communication or Transmission Problem; Communication or Transmission Problem

  THE CUSTOMER REPORTED THAT THEY'RE GETTING COMMUNICATION LOSS ON THIS BEDSIDE MONITOR. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12328860 ↗
• MalfunctionJul 10, 2020No Audible Alarm; Alarm Not Visible; Protective Measures Problem; No Audible Alarm; Alarm Not Visible; Protective Measures Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE ALARMS WERE TURNED OFF AT THE BSM, BUT THE NURSE WAS STATING THEY DID NOT TURN THEM OFF. THE HOSPITAL MANAGEMENT WOULD LIKE THIS INVESTIGATED.

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

  MAUDE report 10261297 ↗