NA PU-621RRecalls & reported problems
Nihon Kohden Corporation · Central Monitoring Station · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This is the Nihon Kohden central monitoring station, a system that displays patient monitoring data at a nursing station. The 1,665 reports often describe communication failures, freezing or unexpected shutdowns, power problems, and display faults. The records include 17 deaths, 6 injuries and 1,641 malfunctions, and 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
- 1,666
- Deaths reported
- 17
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,666 adverse event reports that list this exact device (DI 04931921114131), received between May 11, 2016 and Sep 30, 2026 — classified as 17 deaths, 6 injuries, 1,642 malfunctions.
The most frequently reported specific device problem is “Communication or Transmission Problem” (363 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.
Reports received per month
Most reported problems
Device problems
- Communication or Transmission Problem363
- Application Program Problem279
- Power Problem222
- Output Problem202
- Display or Visual Feedback Problem194
- Unintended Application Program Shut Down185
- No Display/Image157
- Protective Measures Problem121
Patient problems
- No Clinical Signs, Symptoms or Conditions1,081
- No Known Impact Or Consequence To Patient460
- No Consequences Or Impact To Patient307
- Death10
- No Information5
- Patient Problem/Medical Problem5
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
- Arrhythmia3
Recent adverse event reports
The 25 most recent of 1,666 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Unintended Application Program Shut Down
The Biomedical Engineer (BME) reported that the Central Nurse Station (CNS) spontaneously shut down, rebooted and showed an error with illegible characters, and a network service disconnect error. No patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946696 ↗MalfunctionAug 17, 2026Application Program Problem; Unintended Application Program Shut Down
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50278860 ↗MalfunctionJul 14, 2026Application Program Problem; Application Program Freezes or Fails to Launch
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25815459 ↗MalfunctionJun 30, 2026Erratic or Intermittent Display; Intermittent Program or Algorithm Execution
The Biomedical Engineer (BME) reported that the Central Nurse Station (CNS) was unable to consistently access and display Arrhythmia Recall data for all tiles. When attempting to access Arrhythmia Recall data for any tile, the CNS displayed a prolonged "Data Loading" message, followed by intermittent display issues and freezing. The BME had already rebooted the CNS, but the issue persisted. No patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25666454 ↗MalfunctionJun 11, 2026Application Program Problem; Unintended Application Program Shut Down
The Biomedical Engineer (BME) reported that the Central Nurse's Station (CNS) spontaneously shut down. It came back on but he stated the application loaded and is displaying the tiles but it also has a blue screen and is not showing the data of the 1 Tele that is being monitored on the CNS. They tried rebooting but it is not coming back on. Now the monitor is blue so they cannot use it. No patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25473388 ↗MalfunctionMay 11, 2026No Display/Image; Display or Visual Feedback Problem
THE CUSTOMER REPORTED THAT THE SECOND DISPLAY ON THIS CENTRAL NURSE'S STATION (CNS) WENT BLACK AND IS NO LONGER POWERING ON. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25142713 ↗MalfunctionApr 17, 2026Application Program Problem; Unintended Application Program Shut Down
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) WAS INTERMITTENTLY POWERING ON AND OFF. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24917968 ↗MalfunctionApr 15, 2026Communication or Transmission Problem; Operating System Becomes Nonfunctional
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE STATION (CNS) WAS IN PATIENT USE AND STOPPED WORKING. THEY POWERED IT ON, BUT THE CNS WOULD LOSE COMMUNICATION AND FREEZE. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24886728 ↗MalfunctionApr 14, 2026No Display/Image; Display or Visual Feedback Problem
THE CUSTOMER REPORTED THAT THIS CENTRAL NURSE'S STATION (CNS) IS NOT SHOWING A PAP WAVEFORM UNDER INDIVIDUAL WAVEFORMS AND THE PAP OPTION IS NOT SHOWING UP AT ALL UNDER FULL DISCLOSURE FOR DISPLAYED WAVE SETTING OR STORED WAVE SETTINGS. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24877648 ↗MalfunctionApr 10, 2026Incorrect, Inadequate or Imprecise Result or Readings; Output Problem
THE CUSTOMER REPORTED A TIME ISSUE ON THIS CENTRAL NURSE'S STATION (CNS). ACCORDING TO THE CUSTOMER, THEY TRIED TO ADJUST THE TIME; HOWEVER, IT REVERTS TO WHAT IT PREVIOUSLY WAS. THE CUSTOMER ALSO MENTIONED THAT THE RHYTHM IS NOT READING CORRECTLY ON THIS CNS. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24839845 ↗MalfunctionApr 2, 2026Application Program Problem; Unintended Application Program Shut Down
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT SOMEONE TRIPPED OVER THE POWER WIRE ON FRIDAY LAST WEEK AND THE CENTRAL NURSE'S STATION (CNS) HAS BEEN SPONTANEOUSLY BOOT LOOPING SINCE THEN. THE DEVICE IS END OF LIFE. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24772355 ↗MalfunctionApr 1, 2026Unintended Application Program Shut Down
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE STATION (CNS) HAD A BLUE SCREEN DESPITE MULTIPLE ATTEMPTS AT REBOOTING. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24756220 ↗MalfunctionMar 31, 2026Display or Visual Feedback Problem; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED THAT ROOMS 1 AND 7 WERE SENDING THE VITALS TO THE WRONG TILES ON THIS CENTRAL NURSE'S STATION (CNS). ACCORDING TO THE CUSTOMER, BED 7 WAS SHOWING THE VITALS FROM BED 1 AND BED 1 WAS SHOWING THE VITALS FROM BED 7. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24747252 ↗MalfunctionMar 16, 2026No Display/Image; Display or Visual Feedback Problem
THE CUSTOMER REPORTED THAT THIS CENTRAL NURSE'S STATION (CNS) LOST A DISPLAY, THE DEVICE IS DUAL DISPLAY. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24603797 ↗MalfunctionFeb 6, 2026Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem
THE NURSE MANAGER REPORTED THAT FOUR ZM TRANSMITTERS WERE NOT DISPLAYING THE HEART RATE (HR) AT THE CENTRAL NURSE'S STATION (CNS). NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24279873 ↗MalfunctionJan 30, 2026Display or Visual Feedback Problem; Electrical /Electronic Property Problem; Image Display Error/Artifact; Unexpected Shutdown
THE CUSTOMER REPORTED THAT THIS CENTRAL NURSE'S STATION (CNS) DISPLAYED A "FATAL ERROR" MESSAGE BEFORE IT SHUT DOWN. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24220807 ↗MalfunctionJan 23, 2026Application Program Problem; Application Program Freezes or Fails to Launch
THE CUSTOMER REPORTED THAT THIS CENTRAL NURSE'S STATION (CNS) IS NOT LAUNCHING THE CNS SOFTWARE. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24160348 ↗MalfunctionJan 20, 2026No Audible Prompt/Feedback; Audible Prompt/Feedback Problem
THE CUSTOMER REPORTED THAT THE SPO2 ALARM WAS DISCONNECTED AND THE UNIT DID NOT ALARM OR ESCALATE TO CRITICAL AFTER 3 MINUTES. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24115564 ↗MalfunctionJan 8, 2026Application Program Problem; Output Problem
THE CUSTOMER REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) HAS DUAL DISPLAYS, AND BOTH SCREENS ARE BLACK WITH ONE SCREEN SHOWING "OPERATING SYSTEM SETUP". SHE SAID IT HAS BEEN STUCK ON THIS SCREEN FOR QUITE SOME TIME, AND THEY HAVE ALREADY TRIED FORCE REBOOTING WITHOUT SUCCESS. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24015719 ↗MalfunctionDec 31, 2025No Display/Image; No Display/Image
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE STATION (CNS) DISPLAY WAS BLACK WHILE IN PATIENT USE. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23933637 ↗MalfunctionDec 16, 2025Power Problem; Complete Loss of Power; Power Problem; Complete Loss of Power
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) WENT DOWN WHILE MONITORING PATIENTS AND WHEN TRYING TO BOOT IT BACK UP, IT GAVE A "MONITOR NETWORK DISCONNECT" ERROR MESSAGE. IT WOULD NOT CONNECT TO THE NETWORK, AND THEY COULD NOT LAUNCH THE CNS APPLICATION. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23822555 ↗MalfunctionNov 20, 2025Application Program Problem; Unintended Application Program Shut Down; Application Program Problem; Unintended Application Program Shut Down
THE NURSE REPORTED THAT THE CNS APPLICATION ON THE CENTRAL NURSE'S STATION (CNS) SPONTANEOUSLY REBOOTED ON ITS OWN AND WOULD NOT COME BACK UP. WHEN TRYING TO REBOOT THE CNS, SHE RECEIVED SOME KIND OF NETWORK ERROR BUT COULD NOT RECALL WHAT IT SAID. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23610794 ↗MalfunctionNov 19, 2025Electrical /Electronic Property Problem; Unexpected Shutdown; Electrical /Electronic Property Problem; Unexpected Shutdown
THE CUSTOMER REPORTED THAT THIS CENTRAL NURSE'S STATION (CNS) POWERED OFF OVERNIGHT. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23598494 ↗MalfunctionNov 12, 2025Application Program Problem; Application Program Problem
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) FAILED AND THAT THE RAID DRIVE FAILED. THE BIOMED REMOVED THE BACKUP DRIVE FOR THIS UNIT IN THE PAST AND NEVER REPLACED IT, AND THEY DO NOT HAVE A BACKUP. NOT IN PATIENT USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23538407 ↗MalfunctionOct 28, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE SECONDARY DISPLAY ON THIS CENTRAL NURSE STATION (CNS) WAS BLANK AT BOTTOM OF THE SCREEN, BUT THE ALARM INDICATOR WAS WORKING. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23408137 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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