Nihon Kohden Life Scope G5 Bedside Monitoring System CU-152RRecalls & reported problems
Nihon Kohden Corporation · Core Unit · Class 2
All models of Nihon Kohden Life Scope G5 Bedside Monitoring System (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Nihon Kohden Life Scope G5 bedside monitor tracks vital signs like blood pressure and oxygen in hospitals. Reports mostly describe display and output failures, including missing or incorrect blood pressure, oxygen and alarm readings. There are 25 reports naming its identifier, mentioning 2 deaths and no injuries. No recalls name this device, and reports rose with 17 in the last 12 months compared with 4 in the prior 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 26
- Deaths reported
- 2
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 04931921002056), received between Mar 2, 2023 and Sep 25, 2026 — classified as 2 deaths, 24 malfunctions.
The most frequently reported specific device problem is “Output Problem” (10 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.
Reports received per month
Most reported problems
Device problems
- Output Problem10
- Display or Visual Feedback Problem7
- Application Program Freezes or Fails to Launch3
- Application Program Problem3
- Incorrect, Inadequate or Imprecise Result or Readings3
- Protective Measures Problem3
- Unable to Obtain Readings3
- Erratic or Intermittent Display2
Patient problems
- No Clinical Signs, Symptoms or Conditions25
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Output Problem; Tactile Prompts/Feedback; Inappropriate Tactile Prompt/Feedback
The Biomedical Engineer (Biomed) reported that the touchscreen on the G5 Monitor would not appropriately recognize touch inputs when making onscreen selections. No patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50900289 ↗MalfunctionAug 31, 2026Erratic or Intermittent Display; Display or Visual Feedback Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50521702 ↗MalfunctionAug 18, 2026Erratic or Intermittent Display; Display or Visual Feedback Problem; Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50300368 ↗MalfunctionAug 11, 2026Application Program Problem; Application Program Freezes or Fails to Launch
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50207781 ↗MalfunctionJul 27, 2026No Device Output; Device-Device Incompatibility; Compatibility Problem
The Biomedical Engineer (BME) reported that this G5 Monitor would not obtain a Non-Invasive Blood Pressure (NIBP) reading for patients with high blood pressure when this transport monitor was connected. No patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50041802 ↗MalfunctionJul 20, 2026Unable to Obtain Readings; Data Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25883649 ↗DeathJul 20, 2026Unable to Obtain Readings; Output Problem
The Biomedical Engineer (Biomed) reported that the G5 Monitor gave a "No SpO2 Probe Connected" error message and would not pick up SpO2 levels. This occurred while the patient was coding. Although the patient passed away, the onsite "House Super," who was contacted by TS later stated they did not believe the SpO2 issue was the cause of the patient's death.
Patient problems: Insufficient Information
MAUDE report 25879252 ↗DeathJul 6, 2026Device Alarm System; Protective Measures Problem
THE BIOMEDICAL ENGINEER (BME) REPORTED AN ADVERSE EVENT INVOLVING UNCLEAR ALARM BEHAVIOR ON A G5 MONITOR AND CENTRAL NURSE STATION (CNS), WITH INCONSISTENT DESCRIPTIONS OF WHETHER THE ALARM WAS INACTIVE, DISABLED, OR FAILED TO SOUND, AND INCONSISTENT INCIDENT DATES BEFORE FINALLY CONFIRMING ON (B)(6) AT 9:11 AM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25719914 ↗MalfunctionApr 13, 2026Incorrect, Inadequate or Imprecise Result or Readings; Output Problem
THE CUSTOMER REPORTED THAT THIS UNIT DISPLAYED AN INCORRECT MAP. ACCORDING TO THE CUSTOMER, MAP WAS CALCULATED MANUALLY BY THE CLINICAL STAFF TO AVERT POTENTIAL PATIENT HARM. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24860238 ↗MalfunctionMar 23, 2026Application Program Problem; Application Program Freezes or Fails to Launch
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE G5 BEDSIDE MONITOR TOUCHSCREEN FROZE UP AND BECAME UNRESPONSIVE DURING AN OR CASE. HE SAID THE ISSUE WAS RESOLVED BY UNPLUGGING THE POWER AND FORCE SHUTTING DOWN THE UNIT AND TURNING IT BACK ON. HE SAID HE WOULD LIKE TO HAVE THE UNIT EVALUATED. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24671349 ↗MalfunctionMar 20, 2026Application Program Problem: Parameter Calculation Error; Unable to Obtain Readings
THE NURSE REPORTED THAT THE G5 MONITOR WAS RECEIVING "ANALYZING DATA" ON 12-LEAD AND NO 12-LEAD ANALYSIS WERE GIVEN. THE WAVEFORMS WERE DISPLAYED, BUT INTERMITTENTLY. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24648131 ↗MalfunctionFeb 23, 2026Display or Visual Feedback Problem; Detachment of Device or Device Component; Output Problem
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE G5 MONITORING SCREEN FREEZES, REQUIRING THE STAFF TO UNPLUG IT FROM THE ELECTRICAL OUTLET AND PLUG IT BACK IN. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24414572 ↗MalfunctionFeb 19, 2026Display or Visual Feedback Problem
THE CUSTOMER REPORTED THAT THEY NOTICED THIS G5 SWAPPED THE BED ID WITH A G9 IN THE ICU. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24389004 ↗MalfunctionFeb 16, 2026Output Problem
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE G5 BEDSIDE MONITOR WILL INTERMITTENTLY HAVE PIXELED WAVEFORMS. HE SAID THAT IT WILL GO AWAY ONCE YOU REBOOT THE G5 BUT WILL COME BACK AFTER A WHILE. HE SAID THAT IT DOES THIS WITH OR WITHOUT ANYTHING CONNECTED TO THE G5. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24354529 ↗MalfunctionJan 30, 2026Battery Problem; Power Problem
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE BEDSIDE MONITOR (BSM) THE G5 UNIT WOULD TURN OFF DESPITE BEING CONNECTED TO A POWER SOURCE. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24223543 ↗MalfunctionJan 15, 2026Incorrect, Inadequate or Imprecise Result or Readings; Output Problem
THE NK EMPLOYEE, ON BEHALF OF THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE ETCO2 WAVEFORM DISPLAYED WHAT THEY CALLED "TINY SPIKES" ON THE G9 MONITOR. EVERY ROOM DISPLAYED THE SAME SPIKES. THE SPIKES DID NOT DISPLAY ON THE DRAEGER MONITOR FOR THE ANESTHESIA CARTS. ALTHOUGH THE VALUES OF THE PEAKS WERE MATCHING AND WERE SENT TO THE EMR NORMALLY, THE WAVEFORMS MADE IT SEEM LIKE THERE WAS A "0" BETWEEN EACH PEAK. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24081366 ↗MalfunctionDec 2, 2025Power Problem; Complete Loss of Power; Power Problem; Complete Loss of Power
THE CUSTOMER REPORTED THAT THE BEDSIDE MONITOR WAS SHOWING A BATTERY ERROR AND WOULD SHUT OFF ALTHOUGH IT WAS CONNECTED TO AC POWER. THE CUSTOMER REPLACED THE BATTERY AND HAVE NOT HAD ANY ISSUES SINCE. NOT IN PATIENT USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23700600 ↗MalfunctionNov 23, 2025Display or Visual Feedback Problem; Image Display Error/Artifact; Display or Visual Feedback Problem; Image Display Error/Artifact
THE CUSTOMER REPORTED THAT THIS UNIT DISPLAYED A CO2 CONNECTOR OFF ERROR MESSAGE WHENEVER THEY DISCONNECT THE CAP ONE CO2 SENSOR FROM THE INPUT UNIT. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23627587 ↗MalfunctionOct 3, 2025Application Program Problem; Application Program Freezes or Fails to Launch; Application Program Problem; Application Program Freezes or Fails to Launch
THE CUSTOMER REPORTED THAT THIS UNIT LOCKED UP DURING SURGERY AND QUIT MONITORING THE PATIENT. IT IS UNKNOWN WHETHER THERE WAS PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23209317 ↗MalfunctionOct 1, 2025No Audible Alarm; Protective Measures Problem; No Audible Alarm; Protective Measures Problem
THE CUSTOMER REPORTED THAT THIS UNIT MISSED CRISIS ALARMS. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23192706 ↗MalfunctionJun 27, 2025No Display/Image; Output Problem; No Display/Image; Output Problem
THE CUSTOMER REPORTED THAT THE REAR HDMI PORT WAS NOT SENDING DATA TO THE DISPLAY SCREEN. SWAPPING THE MONITOR FOR ANOTHER ONE THAT WAS CONFIGURED IDENTICALLY ALLOWED THE SECONDARY DISPLAY TO WORK WITH NO ISSUES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22350579 ↗MalfunctionDec 26, 2024No Audible Alarm; Protective Measures Problem; No Audible Alarm; Protective Measures Problem
THE CUSTOMER REPORTED THIS UNIT HAD A MISSED ALARM AND THEY WOULD LIKE TO SEND IN THE LOG FILES FOR REVIEW. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21020016 ↗MalfunctionApr 22, 2024Display or Visual Feedback Problem; Image Display Error/Artifact; Display or Visual Feedback Problem; Image Display Error/Artifact
THE BIOMEDICAL ENGINEER (BME) REPORTED THE G5 MONITORING UNIT (G5) HAD VERTICAL STATIC WAVEFORMS DURING PATIENT USE. THERE WAS NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19154765 ↗MalfunctionJun 8, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE CUSTOMER REPORTED THAT THE MONITOR TOUCH CAPABILITIES STOPPED WORKING. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17088634 ↗MalfunctionApr 21, 2023Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem
THE BIOMEDICAL ENGINEER REPORTED RECEIVING AN "INPUT UNIT FAILURE" ERROR MESSAGE ON THE G5 MAX MONITOR. THE MONITOR WAS IN THE "ADMIT" SCREEN. THE UNIT WAS NOT MONITORING A PATIENT AT THE TIME, HOWEVER, THIS WAS THE THIRD OCCURRENCE OF THIS EVENT OVER A PERIOD OF SEVERAL MONTHS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16791949 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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