NA MU-971RARecalls & reported problems

Summary

The FDA's MAUDE database contains 259 adverse event reports that list this exact device (DI 04931921000663), received between May 11, 2016 and Nov 3, 2023 — classified as 1 death, 1 injury, 255 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (50 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 25 most recent of 259 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 3, 2023Communication or Transmission Problem; Communication or Transmission Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE TELEMETRY 5 GROUP IS NOT SHOWING UP AT THE CENTRAL NURSE'S STATION (CNS). NO PATIENT HARM WAS REPORTED. TECHNICAL SUPPORT SUGGESTED FOR THE BME TO REBOOT THE CNS OR ORG BOX ASSOCIATED TO TELE 5 GOUP. TECHNICAL SUPPORT INFORMED THE BME THAT THE MODEL MU-971 HAS BEEN SUNSETTED IN 2011 AND ARE NO LONGER ABLE TO BE SERVICED BY NIHON KOHDEN AND RECOMMENDED THAT THEY PURCHASE A NEWER VERSION OF CNS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18066719 ↗
• MalfunctionDec 2, 2022Output Problem; Output Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) WAS NOT DISPLAYING THE WAVEFORMS FOR ONE OF THE BEDSIDE MONITORS (BSM) BEING MONITORED ON IT. THE NUMERICS DISPLAYED, BUT THE WAVEFORMS WERE NOT. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15902317 ↗
• MalfunctionNov 17, 2022Application Program Problem; Unintended Application Program Shut Down; Application Program Problem; Unintended Application Program Shut Down

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) KEEPS INADVERTENTLY SHUTTING DOWN AND COMING BACK UP. ALSO THE ARRHYTHMIA IS GOING IN AND OUT INTERMITTENTLY. TECH SUPPORT (TS) INFORMED THE CUSTOMER THAT THE DEVICE IS AN END OF LIFE DEVICE AND SOUNDS LIKE THEY ARE HAVING HDD ISSUES. THEY ADVISED THE CUSTOMER TO CONTACT THEIR NK REPRESENTATIVE TO PURCHASE A NEW DEVICE. NOT IN PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15811998 ↗
• MalfunctionJul 13, 2022No Display/Image; Display or Visual Feedback Problem; No Display/Image; Display or Visual Feedback Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) DISPLAY MONITOR HAS A MESSAGE APPEARING OVER THE WINDOWS APPLICATION STATING "DISPLAY SETTINGS FAILED, CHECK DISPLAY SETTINGS" INTERRUPTING THE MONITORING OF THE PATIENTS ON THE CNS. THE CNS MONITORS TRANSMITTERS. NO PATIENT HARM OR INJURY REPORTED. NIHON KOHDEN TECHNICAL SERVICE AGENT HAD THE BME CHECK THE RESOLUTION OF THE DISPLAY MONITOR AND FOUND THE RESOLUTION WAS INCORRECTLY SET AND WHEN THE BME ATTEMPTED TO CORRECT THE SETTING, IT WOULD NOT ACCEPT THE CHANGE. NK TECHNICAL SERVICE AGENT INFORMED THE BME THIS UNIT HAS REACHED THE END OF USEFUL LIFE AND SHOULD BE REMOVED FROM USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15004901 ↗
• MalfunctionMay 20, 2022Device Alarm System; No Audible Alarm; Protective Measures Problem; Device Alarm System; No Audible Alarm; Protective Measures Problem

  THE NURSE REPORTED THAT THEY ARE NOT GETTING ALARMS FROM THE NIBP ON THE CENTRAL NURSE'S STATION (CNS). THEY STATED THAT THEY ARE NOT GETTING ANY NIBP ALARMS FOR PATIENTS ABOVE OR BELOW THE SET NUMBERS OF 170 / 80. THEY ARE REQUESTING TO HAVE A CLINICAL REVIEW OF THE ALARM SETTING ON THIS CNS. ONE OF THE NURSES IN ICU INFORMED HER THAT THEY DO HAVE THE OPTION TO TURN THE ALARMS OFF. THE NURSE ALSO STATED THAT THEY WOULD CALL UP TO THE OTHER DEPARTMENTS TO VERIFY IF THEY ARE CHANGING THESE SETTING AND REACH BACK OUT TO US. TECH SUPPORT (TS) CALLED FOR ADDITIONAL COMPLAINT INFORMATION AND WAS TOLD ALL THEY KNOW WAS THAT THE ISSUE IS RESOLVED, AND THEY DO NOT KNOW HOW IT WAS RESOLVED. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14458706 ↗
• MalfunctionApr 7, 2022Output Problem; Output Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE PATIENT DATA FROM DIFFERENT PATIENTS IS BEING SENT TO ANOTHER PATIENTS EMR RECORD. IN THE EMR FOR BED 1013 IN GROUP ICU-2 MRN: (B)(6), THE A-LINE AND THE ART LINE ARE COMING FROM A DIFFERENT PATIENT WHO IS NOT ON THIS BED. THEY DO NOT KNOW WHERE IT IS COMING FROM AND NEITHER DOES THE NURSE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14048750 ↗
• MalfunctionApr 1, 2022Application Program Problem; Unintended Application Program Shut Down; Application Program Problem; Unintended Application Program Shut Down

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) WILL NOT BOOT UP AT ALL. THEY ARE GETTING AN ERROR THAT SAYS DISK FAILURE. IT WILL NOT BOOT UP THE BIOS OR WINDOWS DESKTOP. THEY HAVE ATTEMPTED TO REBOOT, BUT IT WILL TURN ON AND THE ERROR APPEARS RIGHT AWAY. TECH SUPPORT (TS) TOLD THE CUSTOMER THAT THIS IS A SUNSETTED PRODUCT. IT IS NO LONGER SUPPORTED BY PHONE OR REPAIR. TS ADVISED FOR THEM TO UPGRADE THIS CNS AND TO CONTACT THEIR LOCAL SALES REPRESENTATIVE FOR A QUOTE. THEY UNDERSTOOD AND ASKED FOR AN END OF LIFE LETTER WHICH WAS EMAILED TO THEM. AS THE DEVICE WAS IN PATIENT USE, QA INQUIRED WHAT HAPPENED TO THE UNIT PRIOR TO IT NOT BOOTING UP, BUT THEY HAVE BEEN UNRESPONSIVE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13984831 ↗
• MalfunctionMar 2, 2022Audible Prompt/Feedback Problem; Audible Prompt/Feedback Problem

  THE CUSTOMER REPORTED THAT THERE'S NO SOUND AT CENTRAL NURSE'S STATION (CNS). THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13654684 ↗
• MalfunctionFeb 24, 2022No Display/Image; Output Problem; No Display/Image; Output Problem

  THE NURSE REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) WENT TO A BLUE SCREEN, THEN SHUT OFF, AND WHEN IT CAME BACK ON, IT HAS A MESSAGE "NO VIDEO INPUT" WHILE MONITORING TELEMETRY PATIENTS, SO THEY ARE COMPLETELY DOWN AND CANNOT SEE THE PATIENTS ON THE CNS. THE NURSE REPORTED THAT THEY HAVE ANOTHER CNS IN ANOTHER DEPARTMENT THAT THEY CAN PULL THE TELEMETRY'S UP ON TO CONTINUE MONITORING THE PATIENTS FOR THE TIME BEING. NO PATIENT HARM WAS REPORTED. NIHON KOHDEN TECHNICIAN ADVISED THE NURSE THAT THIS CNS IS AT THE END OF ITS SERVICE/SUPPORT/LIFE AND IT MAY HAVE BAD HARD DRIVES/ GRAPHIC CARDS THAT IS CAUSING THE ISSUE. NK TECHNICIAN MADE SOME SUGGESTIONS TO TRY AND RESOLVE THEIR ISSUE AT THE TIME OF THE CALL BUT THE NURSE WAS NOT ABLE TO DO THE TROUBLESHOOTING AT THE TIME AND WILL GET WITH THEIR BIOMED TO FIGURE OUT WHAT TO DO NEXT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13592717 ↗
• MalfunctionFeb 5, 2022Application Program Problem; Application Program Freezes or Fails to Launch; Application Program Problem; Application Program Freezes or Fails to Launch

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THEY HAD A GENERATOR TEST; AND AFTER IT WAS DONE, THE CENTRAL NURSE'S STATION (CNS) APPLICATION ON THIS UNIT DOES NOT COME BACK UP. THEY SAID THAT THE UNIT IS STUCK ON THE WINDOWS SCREEN, AND THE PROGRAM WILL JUST BLINK AND GO AWAY WHEN THEY TRY TO RESTART IT. TECH SUPPORT (TS) TROUBLESHOOTED WITH THE CUSTOMER, AND THE ISSUE PERSISTED. TS ADVISED THAT THIS WAS AN END OF LIFE DEVICE THAT COULD NOT BE REPAIRED. THE CUSTOMER STATED THEY WOULD REPLACE IT WITH A SPARE CNS THAT THEY HAVE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13466876 ↗
• MalfunctionFeb 1, 2022Electrical /Electronic Property Problem; Unintended Application Program Shut Down; Electrical /Electronic Property Problem; Unintended Application Program Shut Down

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) HAD SHUT ITSELF DOWN WHEN THE MONITOR TECHNICIAN CLICKED DISCHARGE TO MOVE A PATIENT FROM WIRED BEDSIDE MONITOR (BSM) TO A TRANSMITTER. NO PATIENT HARM WAS REPORTED. THE BME ASKED NIHON KOHDEN SERVICE TECHNICIAN HOW TO FIX THIS ISSUE AND NK SERVICE TECHNICIAN ADVISED THAT IT IS LIKELY DUE TO THE CNS HAS REACHED ITS END OF LIFE. THE BME REQUESTED TO SEND IN EVENT LOGS FOR INVESTIGATION OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13419134 ↗
• MalfunctionJan 20, 2022No Display/Image; Complete Loss of Power; No Display/Image; Complete Loss of Power

  THE NURSE REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) WILL POWER DOWN WHEN THEY HAVE A POWER OUTAGE/ SURGE AND THEY HAVE TO DISCONNECT THE CNS POWER AND CONNECT IT BACK IN A CERTAIN METHOD TO GET THE CNS DUAL MONITORS BACK UP. NIHON KOHDEN TECHNICIAN HAD THE NURSE POWER CYCLE THE CNS, WITH THE DUAL MONITOR SWITCH POWERED ON, BUT THE SCREENS STAYED BLACK. NK TECHNICIAN HAD THE NURSE POWER OFF THE DUAL MONITOR SWITCH, AND BOTH SCREENS CAME UP, CURRENTLY BOTH SCREENS ARE WORKING, THE STAFF CAN HEAR ALARMS, AND THE TOUCHSCREEN IS WORKING. NO PATIENT HARM OR MISSED EVENTS REPORTED. NIHON KOHDEN TECHNICIAN REQUESTED THAT THE NURSE HAVE THEIR INFORMATION TECHNOLOGY (IT) DEPARTMENT CONTACT NK TECHNICAL SUPPORT TO TROUBLESHOOT THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13311568 ↗
• MalfunctionJan 20, 2022No Audible Alarm; Protective Measures Problem; Noise, Audible; Audible Prompt/Feedback Problem; No Audible Alarm; Protective Measures Problem; Noise, Audible; Audible Prompt/Feedback Problem

  THE CUSTOMER REPORTED THAT THERE WERE NO AUDIBLE ALARAMS ON THE CENTRAL NURSE'S STATION (CNS). THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13311535 ↗
• MalfunctionJan 13, 2022Communication or Transmission Problem; Communication or Transmission Problem

  THE CUSTOMER REPORTED COMMUNICATION LOSS (COMM LOSS) ON THE CENTRAL NURSE'S STATION (CNS). THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13253368 ↗
• MalfunctionJan 13, 2022Communication or Transmission Problem; Communication or Transmission Problem

  THE CUSTOMER REPORTED COMMUNICATION LOSS (COMM LOSS) ON THE CENTRAL NURSE'S STATION (CNS). THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13253363 ↗
• MalfunctionDec 30, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) WAS REBOOTED AND WHEN IT CAME BACK UP, ALL THE BED-TILES DISPLAYED THE MESSAGE "SYSTEM FAILURE". NO PATIENT HARM WAS REPORTED. NIHON KOHDEN TECHNICIAN REQUESTED THE BME TO PRESS THE SILENCE ALARM BUTTON ON EACH OF THE BEDSIDE MONITORS AND WHEN THEY DID THAT RESOLVED THE FAILURE MESSAGE ON THE CNS. NK TECHNICIAN ADVISED THE BME THAT THE DEVICE HAS REACHED THE END OF LIFE EXPECTANCY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13122730 ↗
• MalfunctionDec 30, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) WAS REBOOTED AND WHEN IT CAME BACK UP, ALL THE BED-TILES DISPLAYED THE MESSAGE "SYSTEM FAILURE". NO PATIENT HARM WAS REPORTED. NIHON KOHDEN TECHNICIAN REQUESTED THE BME TO PRESS THE SILENCE ALARM BUTTON ON EACH OF THE BEDSIDE MONITORS AND WHEN THEY DID THAT RESOLVED THE FAILURE MESSAGE ON THE CNS. NK TECHNICIAN ADVISED THE BME THAT THE DEVICE HAS REACHED THE END OF LIFE EXPECTANCY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13122690 ↗
• MalfunctionDec 17, 2021Display or Visual Feedback Problem; Application Program Problem; Application Program Freezes or Fails to Launch; Display or Visual Feedback Problem; Application Program Problem; Application Program Freezes or Fails to Launch

  THE CUSTOMER REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) WAS FROZEN, AND THE MOUSE AND TOUCHSCREEN WERE NOT WORKING. NO HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13030950 ↗
• MalfunctionDec 17, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE CUSTOMER REPORTED THAT THEIR CENTRAL NURSE'S STATION (CNS) IS FROZEN AND THAT THEY CANNOT USE THEIR MOUSE OR THE TOUCHSCREEN. NO HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13030949 ↗
• MalfunctionNov 23, 2021No Audible Alarm; Audible Prompt/Feedback Problem; No Audible Alarm; Audible Prompt/Feedback Problem

  THE CUSTOMER REPORTED A POSSIBLE MISSED VTAC EVENT. ACCORDING TO THE CUSTOMER, THE PATIENT WENT INTO A VTAC CONDITION, BUT THE CENTRAL NURSE'S STATION (CNS) DID NOT SET/ SOUND AN ALARM. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12866157 ↗
• MalfunctionNov 23, 2021No Audible Alarm; Audible Prompt/Feedback Problem; No Audible Alarm; Audible Prompt/Feedback Problem

  THE CUSTOMER REPORTED A POSSIBLE MISSED VTAC EVENT AT THE CENTRAL NURSE'S STATION (CNS). THE PATIENT WENT INTO A VTAC CONDITION, BUT THE CNS DID NOT SOUND AN ALARM. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12866133 ↗
• MalfunctionOct 29, 2021Communication or Transmission Problem; Communication or Transmission Problem

  THE CUSTOMER REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) WAS DISPLAYING COMM LOSS FOR ALL MONITORED TELEMETRY TRANSMITTERS. THE CUSTOMER TRACED THE NETWORK CABLE BACK TO THE NETWORK SWITCH WHERE HE FOUND THAT THE CABLE WAS UNPLUGGED FROM THE SWITCH. NO HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12723985 ↗
• MalfunctionOct 29, 2021Communication or Transmission Problem; Communication or Transmission Problem

  THE CUSTOMER REPORTED THAT THEIR CENTRAL NURSE'S STATION (CNS) IS SHOWING COMMUNICATION LOSS FOR ALL MONITORED TELE BEDS. THE CUSTOMER TRACED THE NETWORK CABLE BACK TO THE NETWORK SWITCH WHERE HE FOUND OUT THAT THE CABLE WAS UNPLUGGED FROM THE SWITCH. NO HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12723710 ↗
• MalfunctionOct 22, 2021Connection Problem; Connection Problem

  THE CUSTOMER REPORTED THAT THE CENTRAL NURSE'S STATION DISPLAYED A NETWORK DISCONNECT MESSAGE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12684669 ↗
• MalfunctionOct 22, 2021Connection Problem; Connection Problem

  THE CUSTOMER REPORTED THAT THE CENTRAL NURSE'S STATION DISPLAYED A NETWORK DISCONNET MESSAGE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12684579 ↗