Nihon Kohden Life Scope G5 Bedside Monitoring System CU-151RRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 04931921002018), received between Jul 13, 2023 and Aug 31, 2026 — classified as 15 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 18, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2026Application Program Problem; Unintended Application Program Shut Down

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50517140 ↗
• MalfunctionAug 17, 2026Erratic or Intermittent Display; Display or Visual Feedback Problem; Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50282519 ↗
• MalfunctionMay 13, 2026Tactile Prompts/Feedback; No Tactile Prompts/Feedback

  THE BIOMEDICAL ENGINEER (BIOMED) REPORTED THAT THE TOUCHSCREEN ON THE G5 MONITOR WAS NOT RESPONDING TO TOUCH INPUTS. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25163446 ↗
• MalfunctionJan 14, 2026Output Problem

  THE CUSTOMER REPORTED THAT THE G5 BEDSIDE MONITOR (BSM) IS NOT RESPONDING TO TOUCH. THE BSM WAS REBOOTED - NO CHANGE. AFTER REBOOTING HE ALSO TRIED CALIBRATING THE TOUCH SCREEN. THE G5 WOULD IMMEDIATELY GO TO CALIBRATION AND FAILED INSTEAD OF ALLOWING HIM TO AT LEAST ATTEMPT TO CALIBRATE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24075919 ↗
• MalfunctionDec 22, 2025Display or Visual Feedback Problem; Image Display Error/Artifact; Application Program Problem; Application Program Freezes or Fails to Launch; Display or Visual Feedback Problem; Image Display Error/Artifact; Application Program Problem; Application Program Freezes or Fails to Launch

  THE CUSTOMER REPORTED THAT THIS G5 WAS STUCK IN A BOOT LOOP AND NOT DISPLAYING ANY CONTENT. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23863799 ↗
• MalfunctionDec 4, 2025Display or Visual Feedback Problem; Output Problem; Display or Visual Feedback Problem; Output Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE TOUCHSCREEN ON THE G5 MONITOR WAS FREEZING UP WHEN TRYING TO SET IT UP. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23717852 ↗
• MalfunctionOct 17, 2025Application Program Problem; Application Program Freezes or Fails to Launch; Application Program Problem; Application Program Freezes or Fails to Launch

  THE CUSTOMER REPORTED THAT THE TOUCHSCREEN WAS COMPLETELY UNRESPONSIVE WHEN PRESSED. THE ISSUE WAS DISCOVERED BY CLINICAL STAFF DURING PATIENT USE. IT IS UNCLEAR WHETHER THE VITALS WERE STILL ABLE TO BE MONITORED OR IF THE WHOLE UNIT FROZE. THE CUSTOMER HAS BEEN UNRESPONSIVE TO CORRESPONDENCES. THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23330611 ↗
• MalfunctionAug 27, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE NK EMPLOYEE REPORTED THAT THE G5 MONITORING UNIT WITH A BSM-1700 FOR THE INPUT UNIT WOULD NOT TAKE NIBP READINGS FOR PATIENTS WITH HIGH BLOOD PRESSURE (BP). THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22902878 ↗
• MalfunctionAug 18, 2025Application Program Problem; Application Program Freezes or Fails to Launch; Application Program Problem; Application Program Freezes or Fails to Launch

  THE CUSTOMER REPORTED THAT THE G5 BEDSIDE MONITOR WAS UNRESPONSIVE. IT IS WAS UNCLEAR IF THE JUST THE TOUCHSCREEN WAS UNRESPONSIVE TO TOUCH OR IF THE UNIT WAS FROZEN. NOT IN PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22835669 ↗
• MalfunctionJun 27, 2025Computer Software Problem; Output Problem; Unintended Application Program Shut Down; Computer Software Problem; Output Problem; Unintended Application Program Shut Down

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT TOUCHSCREEN FOR THE BEDSIDE MONITOR (BSM) WAS UNRESPONSIVE. THE BME TRIED CONNECTING A MOUSE TO ATTEMPT TO CALIBRATE THE TOUCHSCREEN, BUT IT WAS NOT RESPONSIVE. WHEN FIRST TRYING TO EVALUATE THE MONITOR, THE BME HAD HIS FINGERS AROUND THE BEIGE PORTION OF THE FRAME AND HEARD A TONE THAT SOUNDED LIKE A TOUCH RESPONSE, BUT A MENU POPPED UP AND HE WAS UNABLE TO X OUT OF THAT. REBOOTING THE MONITOR WITHOUT THE POWER CORD DID NOT RESOLVE THE ISSUE. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22349427 ↗
• MalfunctionDec 26, 2024Unable to Obtain Readings; Output Problem; Unable to Obtain Readings; Output Problem

  THE CUSTOMER REPORTED THAT THE GAS ANALYZER WAS NOT TAKING READINGS WHILE ON A CASE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21020594 ↗
• MalfunctionDec 20, 2024Computer Software Problem; Loss of Power; Unintended Application Program Shut Down; Computer Software Problem; Loss of Power; Unintended Application Program Shut Down

  BIOMEDICAL ENGINEER (BME) REPORTED THAT THE G5 MONITOR HAD CRASHED AND BOOTED INTO THE DEEP SETTINGS, THIS HAPPENED AFTER WORK HOURS. THE NURSING STAFF REPORTED TO THE BME THAT IT WOULD CONSTANTLY REQUEST THEM TO ENTER THE PASSWORD TO GET INTO THE DEEP SETTINGS. BME PROVIDED THE NURSING STAFF WITH THE PASSWORD. AFTER THE BME ARRIVED AT THE HOSPITAL, THE UNIT WAS BACK UP AND RUNNING. HOWEVER, ALL SETTINGS HAD BEEN RESET AND BME HAD TO RECONFIGURE THE UNIT. BME REQUESTED THAT NK TAKE A LOOK AT THE LOGS TO SEE WHY THE G5 MONITOR CRASHED. THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20992832 ↗
• MalfunctionApr 18, 2024Display or Visual Feedback Problem; Image Display Error/Artifact; Display or Visual Feedback Problem; Image Display Error/Artifact

  THE CUSTOMER REPORTED THAT THIS UNIT HAS HAD A VERTICAL STATIC BAR LIKE INTERFERENCE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19134667 ↗
• MalfunctionFeb 13, 2024Unintended Application Program Shut Down; Unintended Application Program Shut Down

  NK EMPLOYEE FIELD SUPPORT REPORTED THAT THE G5 MONITORING UNIT WAS SPONTANEOUSLY REBOOTING. NOT IN PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18699745 ↗
• MalfunctionJul 13, 2023No Device Output; Output Problem; No Device Output; Output Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED HAVING ISSUES WITH SPO2 AND ECG CABLES WHEN CONNECTED TO THE G5 UNITS IN COMBINATION WITH THE BEDSIDE MONITORS (BSM-1700). AFTER THE CABLES WERE USED FOR A LONG TIME, THEY WOULD NO LONGER REGISTER WITH THAT DEVICE. NOT IN PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17320005 ↗