Nihon Kohden NKV-440 (UDI 00843685100166)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00843685100166), received between May 15, 2025 and Apr 2, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Inappropriate or Unexpected Reset” (5 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.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2026Inappropriate or Unexpected Reset

  THE PATIENT WAS PLACED ON NCPAP FOR OXYGEN SUPPORT USING THE NKV-440 VENTILATOR. THE DEVICE INITIALLY FUNCTIONED AS EXPECTED AND PROVIDED ADEQUATE VENTILATORY SUPPORT FOR APPROXIMATELY THE FIRST 10 MINUTES OF THERAPY. AFTER APPROXIMATELY 15 MINUTES OF CONTINUOUS USE, THE VENTILATOR SCREEN SUDDENLY WENT BLACK WITH NO ALARMS. AS A PRECAUTION, THE DECISION WAS MADE TO REPLACE THE DEVICE. THE PATIENT WAS TRANSFERRED TO ANOTHER VENTILATOR. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24766892 ↗
• MalfunctionMar 16, 2026Computer Software Problem; Inappropriate or Unexpected Reset

  DURING PATIENT USE, THE RESPIRATORY THERAPIST (RT) OBSERVED THAT THE VENTILATOR'S GRAPHIC USER INTERFACE (GUI) WENT COMPLETELY BLACK, WITH NO GRAPHICS OR DISPLAY INFORMATION VISIBLE. PRIOR TO THE EVENT, THE RT HAD MADE VENTILATOR SETTING CHANGES AND STEPPED AWAY TO CHART. APPROXIMATELY 30¿60 SECONDS LATER, THE RT NOTICED THAT THE GUI HAD GONE BLACK. DESPITE THE BLACK GUI, THE VENTILATOR CONTINUED TO OPERATE AND DELIVER BREATHS TO THE PATIENT. THE GUI'S LOCK BUTTON WAS ILLUMINATED BUT DID NOT RESPOND TO TOUCH INPUT. NO AUDIBLE OR VISUAL ALARMS WERE REPORTED. THERE WAS NO PATIENT HARM. THE PATIENT WAS TRANSFERRED TO ANOTHER NKV-440 VENTILATOR, AND THE AFFECTED DEVICE WAS REMOVED FROM PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24610608 ↗
• MalfunctionFeb 13, 2026Computer Software Problem; Inappropriate or Unexpected Reset

  DURING PATIENT USE, THE RESPIRATORY THERAPIST OBSERVED THAT THE VENTILATOR TOUCHSCREEN WAS COMPLETELY BLACK, WITH NO GRAPHICS OR DISPLAY INFORMATION VISIBLE. DESPITE THE BLANK SCREEN, THE VENTILATOR CONTINUED TO OPERATE AND DELIVER BREATHS TO THE PATIENT. THE SCREEN LOCK BUTTON WAS ILLUMINATED BUT WAS NON-RESPONSIVE TO TOUCH INPUT. THERE WAS NO PATIENT HARM, AND THE PATIENT WAS TRANSFERRED TO ANOTHER NKV-440 VENTILATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24338889 ↗
• MalfunctionDec 2, 2025Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  DURING PATIENT USE, THE NURSE THOUGHT THAT THE NKV-440 VENTILATOR HAD SHUT DOWN BECAUSE THE GRAPHIC USER INTERFACE (GUI) WENT DARK. AS THE NURSE PREPARED TO MANUALLY VENTILATE THE PATIENT, THE GUI AUTOMATICALLY RESUMED NORMAL FUNCTION. WHEN IT RESTARTED, IT DISPLAYED THE ALERT MESSAGE: ¿UNIT RESTARTED (GUI), CHECK SETTINGS, CHECK APPS.¿ THERE WAS NO HARM TO THE PATIENT AND NO DESATURATION EVENTS. THE PATIENT WAS SUBSEQUENTLY PLACED ON ANOTHER VENTILATOR. THE REPORTING HOSPITAL WAS UNABLE TO PROVIDE PATIENT DEMOGRAPHICS. THE VENTILATOR LOGS INDICATED THAT A CRITICAL EXCEPTION OCCURRED, TRIGGERING A GRAPHIC USER INTERFACE (GUI) RESTART. DURING THE RESTART, THE GUI BECAME TEMPORARILY UNRESPONSIVE TO TOUCH, AND WAVEFORM AND PATIENT DATA UPDATES WERE MOMENTARILY PAUSED. THE VENTILATOR'S BREATH DELIVERY UNIT (BDU) CONTINUED TO PROVIDE VENTILATION THROUGHOUT THE EVENT. THE GUI RECOVERED AFTER APPROXIMATELY 61 SECONDS, AND THE SYSTEM RESUMED NORMAL OPERATION WITHOUT ANY ADDITIONAL USER INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23698182 ↗
• MalfunctionNov 17, 2025Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT DURING PATIENT USE, THE VENTILATOR DISPLAYED THE ALARM MESSAGE ¿UNIT RESTARTED (GUI), CHECK SETTINGS & APPS.¿ THE MESSAGE WAS HIGHLIGHTED IN GREEN AND DID NOT PRODUCE AN AUDIBLE ALARM. THE VENTILATOR CONTINUED TO PROVIDE VENTILATION TO THE PATIENT, AND THE PATIENT WAS SUBSEQUENTLY PLACED ON ANOTHER VENTILATOR. NO PATIENT HARM WAS REPORTED. THE VENTILATOR LOGS INDICATED THAT A CRITICAL EXCEPTION OCCURRED, TRIGGERING A GRAPHIC USER INTERFACE (GUI) RESTART. DURING THE RESTART, THE GUI BECAME TEMPORARILY UNRESPONSIVE TO TOUCH, AND WAVEFORM AND PATIENT DATA UPDATES WERE MOMENTARILY PAUSED. THE VENTILATOR CONTINUED TO PROVIDE VENTILATION THROUGHOUT THE EVENT. THE GUI RECOVERED AFTER APPROXIMATELY 37 SECONDS, AND THE SYSTEM RESUMED NORMAL OPERATION WITHOUT ANY USER INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23576872 ↗
• MalfunctionSep 19, 2025Computer Software Problem; Insufficient Device Problem Information; Computer Software Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING PATIENT USE, THE ATTENDING NURSE NOTED THAT THE DEVICE HAD BEEN OPERATING NORMALLY WHEN THE DOCTOR NOTICED THAT THE TOUCHSCREEN HAD GONE BLACK. THE VENTILATOR CONTINUED TO VENTILATE THE PATIENT. THERE WAS NO PATIENT HARM, AND THE PATIENT WAS PLACED ON ANOTHER VENTILATOR. THE SERVICE ENGINEER CHECKED ALL CABLES TO THE MAINBOARD. ALL OF THE CABLES LOOKED NORMAL AND WERE CORRECTLY CONNECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23097514 ↗
• MalfunctionMay 15, 2025Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A VENTILATOR DEMONSTRATION WITH NO PATIENT INVOLVEMENT, THE VENTILATOR'S BRIGHTNESS AUTOMATICALLY DIMMED FROM THE BRIGHTEST TO THE DARKEST LEVEL MULTIPLE TIMES THROUGHOUT THE DEMONSTRATION, WITH THE VENTILATOR ATTACHED TO A TEST LUNG. THE VENTILATOR REPRESENTATIVE WAS ABLE TO RETURN TO THE HIGHEST BRIGHTNESS USING THE QUICK ACCESS BUTTONS EACH TIME. THE VENTILATOR REPRESENTATIVE ALSO STATED THAT SHE PUT THE VENTILATOR IN THE ¿STBY MODE¿ AND THEN PRESSED THE ¿START UP SETTINGS¿ BUTTON, AND THE VENTILATOR SHUT DOWN ON ITS OWN. SHE WAS ABLE TO POWER THE VENTILATOR BACK ON AND HAD NO MORE ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22027768 ↗