CNS-2101 Central MonitorRecalls & reported problems
Nihon Kohden Corporation · Central Monitor · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Nihon Kohden CNS-2101 central monitor is a hospital nursing station system that pulls patient vital signs to bedside screens. Reports mostly describe the software crashing or rebooting on its own, screens going blank or losing patient data, and touchscreens registering false touches or ignoring real ones. Out of 72 reports, 3 mention deaths and 1 mentions an injury. No recalls name this device.
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
- 76
- Deaths reported
- 3
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 76 adverse event reports that list this exact device (DI 04931921017159), received between May 9, 2024 and Sep 11, 2026 — classified as 3 deaths, 1 injury, 72 malfunctions.
The most frequently reported specific device problem is “Output Problem” (17 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 Problem17
- Protective Measures Problem16
- Unintended Application Program Shut Down16
- Application Program Problem14
- Device Alarm System12
- Display or Visual Feedback Problem12
- No Audible Alarm8
- Communication or Transmission Problem6
Patient problems
- No Clinical Signs, Symptoms or Conditions75
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 76 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 11, 2026Defective Alarm; Protective Measures Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50738003 ↗MalfunctionSep 10, 2026Display or Visual Feedback Problem; Unable to Obtain Readings; Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50718099 ↗MalfunctionSep 9, 2026Tactile Prompts/Feedback; No Tactile Prompts/Feedback
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50699207 ↗MalfunctionSep 2, 2026Erratic or Intermittent Display; Display or Visual Feedback Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50566079 ↗MalfunctionAug 31, 2026Incorrect, Inadequate or Imprecise Result or Readings; Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50531912 ↗MalfunctionAug 11, 2026Application Program Problem; Unintended Application Program Shut Down
The Biomedical Engineer (BME) The customer reported that the Central Nurse's Station (CNS) has been spontaneously rebooting itself regularly. The unit comes back online on its own. Latest reported reboot was July 2nd around 14:30 EST.This CNS is also rebooted for preventative maintenance on a regular basis. No patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50202087 ↗InjuryAug 6, 2026Device Alarm System; Protective Measures Problem
The Biomedical Engineer (BME) reported that the Central Nurse Station (CNS) did not alarm that a patient's SpO2 readings were low and the patient coded, but they did not expire. The end users stated they did not silence or turn off the SpO2 alarm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50159578 ↗MalfunctionJul 31, 2026Display Difficult to Read; Display or Visual Feedback Problem; Output Problem
The Biomedical Engineer (Biomed) reported that the patients' vitals at the Central Nurse's Station (CNS) disappeared on the left side of each display screen. It was down for 10-15 minutes. No patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50105109 ↗MalfunctionJul 29, 2026Defective Alarm; Protective Measures Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50072295 ↗MalfunctionJul 27, 2026Tactile Prompts/Feedback; No Tactile Prompts/Feedback
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50011245 ↗MalfunctionJul 27, 2026Tactile Prompts/Feedback; No Tactile Prompts/Feedback
The Biomedical Engineer (Biomed) reported that both the main and secondary touchscreens on the CNS were registering false touch inputs. This issue would also sometimes prevent the touchscreens from recognizing actual user touch inputs, requiring the user to keep clicking until it responded or they would have to restart the CNS. No patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50008587 ↗MalfunctionJul 20, 2026Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25873247 ↗MalfunctionJul 14, 2026Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25814080 ↗MalfunctionJul 10, 2026Device Alarm System; No Audible Alarm; Protective Measures Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25786275 ↗DeathJul 8, 2026Device Alarm System; Protective Measures Problem
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT A PATIENT EXPIRED ON THE (B)(6) 2026 AT 1:15AM AND WERE UNSURE IF THE ALARMS WERE PRESENT AT THE CENTRAL NURSE STATION (CNS).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25750821 ↗MalfunctionJul 1, 2026Unintended Application Program Shut Down
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE STATION (CNS) SPONTANEOUSLY REBOOTED ON JUNE 1ST AROUND 13:52 AND AGAIN ON JUNE 7TH AROUND 13:50. THEY WOULD LIKE THE LOGS REVIEWED. NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25682073 ↗MalfunctionJun 30, 2026Device Alarm System; Use of Device Problem; Protective Measures Problem
The customer's Patient Safety Manager reported that a nurse knew the password and was disabling critical alarms at the Central Nurse Station (CNS). The customer stated that were multiple events where they turned the alarm off. They initially stated there was no patient harm, but the issue placed a patient at risk.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25672288 ↗MalfunctionJun 30, 2026Power Problem; Complete Loss of Power
THE NURSE REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) MADE A LOUD NOISE AND THEN SHUT DOWN ON ITS OWN. WHEN BOOTING BACK UP, IT DISPLAYED A "DEVICE COUNT ERROR" MESSAGE. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25668262 ↗MalfunctionJun 25, 2026Device Alarm System; Protective Measures Problem
THE CUSTOMER REPORTED THAT A V-FIB ALARM FROM THE GZ TRANSMITTER WAS NOT SENT TO THE PATIENT'S HX MODULE. HE STATED THE ALARM WAS CAPTURED AND ACKNOWLEDGED IN THE SICKBAY SYSTEM BUT WAS CONCERNED THAT THE CNS DID NOT ALARM. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25628011 ↗MalfunctionJun 18, 2026Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE BIOMEDICAL ENGINEER (BIOMED) REPORTED THAT THE ZM TRANSMITTER STOPPED GIVING ECG HEART RATE (HR) READINGS WHILE IN PATIENT USE. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25552925 ↗MalfunctionJun 18, 2026Display or Visual Feedback Problem; Tactile Prompts/Feedback; No Tactile Prompts/Feedback; Activation Problem
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE TOUCHSCREEN ON THE SECONDARY DISPLAY FOR THE CENTRAL NURSE'S STATION (CNS) WAS UNRESPONSIVE. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25552122 ↗MalfunctionJun 16, 2026Application Program Problem
The Biomedical Engineer (BME) reported that the touch is non responsive on 2nd Monitor of the Central Nurse's Station (CNS). He is able to use the mouse on the screen but just not the touch. No patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25523774 ↗MalfunctionJun 16, 2026Application Program Problem; Unintended Application Program Shut Down
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) WAS SPONTANEOUSLY REBOOTING. PRIOR TO THE CALL, HE NOTES THAT IT HAD REBOOTED BETWEEN 10-20 TIMES. HE ADDED THAT THERE WERE NO POWER OUTAGES, AND THE REBOOT HAPPENED ALL OF A SUDDEN BY ITSELF. HE EXPLAINED THAT THE ALARM BEEPED, THEN THE WHITE ALARM LIGHT FLASHED, THEN THE UNIT SHUT OFF AND JUST KEPT REBOOTING ITSELF. TECH SUPPORT (TS) HAD THE CUSTOMER FORCE SHUT DOWN THE UNIT, AND WE KEPT THE UNIT OFF FOR 5 MINUTES. TS ALSO HAD THE CUSTOMER RE-SEAT THE ETHERNET CABLE ON BOTH ENDS AND MADE SURE HE FELT THE SNAP. HE THEN TURNED THE UNIT BACK ON AND THE CNS APPLICATION LOADED SUCCESSFULLY. HE REPORTED THAT HE CAN SEE PATIENT NAMES, WAVEFORMS, AND DATA. TS ASKED IF HE WANTED TO COLLECT LOGS FOR US TO INVESTIGATE BUT HE DECLINED AND REQUESTED TO CLOSE THE TICKET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25523747 ↗MalfunctionJun 9, 2026Output Problem; Key or Button Unresponsive/not Working
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE SECONDARY TOUCHSCREEN DISPLAY (A/E355203, SN:(B)(6)) ON THIS CENTRAL NURSE'S STATION (CNS-2101 SN: (B)(6)) WAS CONTINUOUSLY LOSING ITS TOUCH FUNCTIONALITY. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25449595 ↗MalfunctionMay 19, 2026No Audible Alarm; Protective Measures Problem
THE CUSTOMER REPORTED THAT THIS CENTRAL NURSE'S STATION (CNS) STOPPED ALARMING AUDIBLY. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25217382 ↗
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- eCareManager 4.5Visicu, Inc. · System, network and communication, physiological monitors1 recall1 death1 report
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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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