Nihon Kohden NKV-330Recalls & reported problems

Summary

The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 00843685100043), received between Jul 13, 2023 and May 11, 2026 — classified as 69 malfunctions.

The most frequently reported specific device problem is “Computer Software Problem” (27 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 69 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE RESPIRATORY THERAPIST (RT) WAS ADJUSTING THE PATIENT INTERFACE TO ACHIEVE AN ADEQUATE MASK SEAL. THE VENTILATOR WAS REPORTED AS ¿NOT WORKING¿ AND APPEARED TO SHUT OFF DURING USE. NO WAVEFORMS WERE OBSERVED ON THE DEVICE DISPLAY AT THE TIME OF THE REPORTED EVENT. THE PATIENT WAS SUBSEQUENTLY INTUBATED AND TRANSITIONED TO AN ALTERNATE VENTILATOR. NO OTHER HARM, SEVERE INJURY, OR DEATH WAS REPORTED. THE DEVICE LOG DATA ANALYSES PERFORMED BY NIHON KOHDEN ORANGEMED INDICATED THERE WAS NO VENTILATOR SHUTDOWN OR ANY SIMILAR EVENT. DELIVERED FLOW WAS MAINTAINED THROUGHOUT THE VENTILATION PERIOD FROM THE START OF VENTILATION UNTIL THE END OF VENTILATION, INDICATING THAT VENTILATION CONTINUED. NIHON KOHDEN ORANGEMED CONCLUDED THAT THE VENTILATOR PERFORMED AS DESIGNED WITH NO INDICATION OF MALFUNCTION.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 25138053 ↗
• MalfunctionApr 11, 2026Inappropriate or Unexpected Reset

  CUSTOMER REPORTED THAT NKV-330 (S/N (B)(6)) EXPERIENCED AN ISSUE DURING PATIENT USE IN WHICH THE DISPLAY SCREEN SUDDENLY WENT BLACK AND THEN TURNED BLUE. A SOUND SIMILAR TO A PHONE RINGING WAS HEARD, AND NO AIRFLOW OR AUDIBLE ALARMS WERE NOTED AT THAT TIME. THE MESSAGE ¿CPU REBOOTED¿ SUBSEQUENTLY APPEARED ON THE SCREEN AS THE VENTILATOR RESUMED NORMAL OPERATION. THERE WAS NO PATIENT HARM, AND THE PATIENT WAS PLACED ON ANOTHER VENTILATOR. FOLLOWING THE EVENT, THE BIOMEDICAL ENGINEER PERFORMED A BREATH DELIVERY VERIFICATION TEST FOR APPROXIMATELY 12 HOURS, DURING WHICH NO ABNORMALITIES WERE OBSERVED. HOWEVER, THE UNIT LATER DISPLAYED AN ¿SD CARD 1 FAULT¿ MESSAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24847309 ↗
• MalfunctionMar 16, 2026Insufficient Device Problem Information; Noise, Audible

  IT WAS REPORTED THAT, WHEN THE VENTILATOR WAS PLACED ON TWO DIFFERENT PATIENTS, A LOUD WHISTLING SOUND WAS HEARD WHEN THE PATIENTS INITIATED A BREATH. ONE PATIENT WAS REMOVED FROM THE NKV-330 VENTILATOR WITHIN APPROXIMATELY FIVE MINUTES OF INITIATION. THE OTHER PATIENT WAS REMOVED FROM THE VENTILATOR AND WAS NOT PLACED ON ANOTHER DEVICE. BOTH INCIDENTS REPORTED THAT THE VENTILATOR CONTINUED TO DELIVER VENTILATION AS INTENDED DURING USE, AND NO ALARMS WERE PRESENT. THERE WAS NO HARM OR INJURY TO EITHER PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24610807 ↗
• MalfunctionJan 14, 2026Inappropriate or Unexpected Reset

  A RESPIRATORY THERAPIST REPORTED THAT THE VENTILATOR SHUT DOWN AND THEN REBOOTED DURING PATIENT USE. THE DEVICE HAD AN AUDIBLE ALARM AND DISPLAYED A ¿CPU REBOOT¿ ALERT MESSAGE. THE PATIENT WAS TRANSITIONED TO ANOTHER VENTILATOR. NO PATIENT HARM WAS REPORTED, AND NO PATIENT DEMOGRAPHICS WERE PROVIDED. REVIEW OF THE DEVICE LOGS CONFIRMED THAT A GRAPHIC USER INTERFACE (GUI) CPU REBOOT OCCURRED. THE NKV-330 CONTINUES VENTILATION OPERATIONS DURING THE GUI CPU REBOOT; THERE IS NO INTERRUPTION IN PATIENT VENTILATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24075056 ↗
• MalfunctionDec 4, 2025Improper Flow or Infusion; Insufficient Device Problem Information; Improper Flow or Infusion; Insufficient Device Problem Information

  DURING PATIENT USE WITH NON-INVASIVE POSITIVE PRESSURE VENTILATION (NIPPV), THE RESPIRATORY THERAPIST (RT) OBSERVED INCONSISTENT VOLUME DELIVERY, RANGING FROM APPROXIMATELY 600 TO 1000 ML. THE PATIENT BECAME UNCOMFORTABLE, WITH SPO2 DROPPING INTO THE 80S AND RISING CO2 LEVELS DESPITE HIGH FIO2. THE VENTILATOR ALSO DISPLAYED A ¿LOW FIO2¿ ALARM. THE RT TRANSFERRED THE PATIENT TO ANOTHER NKV-330 VENTILATOR USING THE SAME SETTINGS. AFTERWARD, SPO2 AND CO2 LEVELS IMPROVED, AND THE PATIENT APPEARED MORE COMFORTABLE. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23723121 ↗
• MalfunctionDec 2, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT SHORTLY AFTER A PATIENT WAS PLACED ON THE VENTILATOR, THE DEVICE GENERATED A ¿COOLING FAN FAULT¿ ALARM. THE VENTILATOR CONTINUED TO VENTILATE THE PATIENT, AND THERE WAS NO PATIENT HARM. THE PATIENT WAS PLACED ON ANOTHER VENTILATOR. THE REPORTING HOSPITAL WAS UNABLE TO PROVIDE PATIENT DEMOGRAPHIC INFORMATION. THE LOGS CONFIRMED ACTIVATION OF THE COOLING FAN FAULT ALERT. THE BIOMEDICAL ENGINEER FOUND THAT THE FILTER WAS FOLDED OVER DURING TROUBLESHOOTING. AFTER REPOSITIONING THE FILTER CORRECTLY, THE FAULT CLEARED AND NO FURTHER ERROR MESSAGES WERE OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23697926 ↗
• MalfunctionNov 17, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT APPROXIMATELY 10 MINUTES AFTER BEING CONNECTED TO A PATIENT AND INITIATING VENTILATION, THE VENTILATOR DISPLAYED A ¿VENT INOP 00001¿ ALARM WITH THE MESSAGE, ¿DEVICE INITIALIZATION WAS NOT COMPLETED, PLEASE RESTART VENTILATION.¿ THE PATIENT WAS PLACED ON ANOTHER NKV-330 VENTILATOR, WITH NO PATIENT HARM. AFTER THE VENTILATOR WAS REMOVED FROM SERVICE, THE CUSTOMER ATTEMPTED TO POWER THE UNIT BACK ON; HOWEVER, THE SAME ¿VENT INOP 00001¿ ERROR REAPPEARED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23577487 ↗
• MalfunctionJul 30, 2025Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT THE NKV-330 VENTILATOR SPONTANEOUSLY TURNED OFF WHILE THE PATIENT WAS ON BIPAP. WHEN THE RESPIRATORY THERAPIST (RT) TURNED THE VENTILATOR BACK ON, THE BATTERY WAS READING 2%. THE RT VERIFIED THAT THE VENTILATOR WAS PLUGGED INTO A RED AC OUTLET. THE RT SWITCHED AC OUTLETS AND CHECKED THE AC CABLE CONNECTION ON THE VENTILATOR. THE VENTILATOR'S BATTERY WOULD NOT CHARGE, AND SHOWED AN ALARM "DO NOT HOT-SWAP MAIN BATTERY, SO THE PATIENT WAS PLACED ON ANOTHER VENTILATOR. THE HOSPITAL REPORTED NO HARM TO THE PATIENT. THE LOGS SHOWED THAT THE VENTILATOR HAD NOT BEEN CONNECTED TO AC POWER AND HAD BEEN RUNNING ON THE MAIN BATTERY FOR 3 HOURS, 55 MINUTES, AND 54 SECONDS BEFORE SWITCHING TO THE BACKUP BATTERY FOR 52 MINUTES AND 57 SECONDS BEFORE BOTH BATTERIES WERE DEPLETED. THE VENTILATOR HAD HIGH-PRIORITY ALARMS (MAIN BATTERY EMPTY AND AC POWER LOSS/BACKUP BATTERY IN USE) FOR 75 MINUTES PRIOR TO VENTILATOR SHUTDOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22672283 ↗
• MalfunctionJul 17, 2025Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT WHEN USING A SMALL VOLUME NEBULIZER INLINE WITH THE NKV-330 VENTILATOR, IT WOULD ALARM 'CIRCUIT OCCLUSION'. THE VENTILATOR CONTINUED TO VENTILATE THE PATIENT. THERE WAS NO HARM TO THE PATIENT. THE REPORTING HOSPITAL COULD NOT SHARE PATIENT DEMOGRAPHICS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22536486 ↗
• MalfunctionJun 23, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT DURING PATIENT USE, THE VENTILATOR DISPLAYED ¿HIGH FIO2' AND 'CIRCUIT OBSTRUCTION' ALARM MESSAGES. THE VENTILATOR CONTINUED TO VENTILATE THE PATIENT. THE SET FIO2 WAS 40%, AND THE MEASURED FIO2 WAS 84%. THE RESPIRATORY THERAPIST REPLACED THE CIRCUIT AND ATTEMPTED TO TROUBLESHOOT THE ISSUES, BUT THE ALARM MESSAGES PERSISTED. THE CIRCUIT CHECK AND O2 SENSOR CALIBRATIONS PASSED BEFORE PATIENT USE. THERE WAS NO NEBULIZER IN USE. THERE WAS NO HARM TO THE PATIENT, AND THE PATIENT WAS PLACED ON ANOTHER VENTILATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22307947 ↗
• MalfunctionJun 23, 2025Defective Component; Defective Component

  THE RESPIRATORY THERAPIST REPORTED THAT DURING PATIENT USE, THE NKV-330 VENTILATOR HAD A 'HIGH FIO2' ALARM MESSAGE. THE SET FIO2 WAS 35%, AND THE MEASURED FIO2 WAS 42%. THE VENTILATOR CONTINUED TO VENTILATE THE PATIENT. THERE WAS NO PATIENT HARM. THE PATIENT WAS PLACED ON ANOTHER VENTILATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22307925 ↗
• MalfunctionMay 22, 2025Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT DURING PATIENT USE, THE VENTILATOR DISPLAYED A 'TECHNICAL FAULT 00006'. THE RESPIRATORY THERAPIST CHECKED THE CIRCUIT AND NOTICED NO BLOCKAGE. WHEN THE 'TECHNICAL FAULT 00006' ALARM MESSAGE WAS DISPLAYED, THERE WERE AUDIBLE ALARMS. THE PATIENT WAS PLACED ON ANOTHER VENTILATOR, AND NO HARM WAS REPORTED. THE REPORTING HOSPITAL IS UNABLE TO SHARE PATIENT DEMOGRAPHICS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22075430 ↗
• MalfunctionMay 22, 2025Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT THE VENTILATOR DISPLAYED A 'VENT INOP 00007' ALARM MESSAGE DURING PATIENT USE. NO PATIENT INJURY WAS REPORTED. NIHON KOHDEN ORANGEMED (NKOM) WAS UNABLE TO OBTAIN ANY OTHER INFORMATION FROM THE INITIAL REPORTER, SUCH AS PATIENT DEMOGRAPHICS AND CONTEXT PRIOR TO THE ALARM, EVEN WITH MULTIPLE ATTEMPTS BY NKOM AND ITS DISTRIBUTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22075426 ↗
• MalfunctionMay 22, 2025Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT DURING PATIENT USE THE VENTILATOR HAD "VENT INOP 00001" AND "TECHNICAL FAULT 00007" ALARMS. THE VENTILATOR THEN TURNED OFF BY ITSELF. THE PATIENT WAS PLACED ON ANOTHER VENTILATOR, AND NO HARM WAS REPORTED. THE REPORTING HOSPITAL IS UNABLE TO PROVIDE PATIENT DEMOGRAPHICS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22075425 ↗
• MalfunctionApr 28, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT THE NKV-330 VENTILATOR BLOWER WAS MAKING A LOUD, PERSISTENT 'CHATTERING' NOISE DURING THE EXPIRATORY PHASE OF VENTILATION. THE VENTILATOR CONTINUED VENTILATING THE PATIENT, AND THE PATIENT WAS PLACED ON ANOTHER VENTILATOR. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21922062 ↗
• MalfunctionMar 21, 2025High Readings; High Readings

  IT WAS REPORTED THAT THE USER WAS TESTING TWO DIFFERENT NKV-330 VENTILATORS ON A PATIENT WITH THE SAME SETTINGS AND MASK. THIS VENTILATOR DISPLAYED LARGER TIDAL VOLUME (VT) MEASUREMENTS THAN THE OTHER ONE (THE ONE THE USER FELT WAS ¿NORMAL¿), ALTHOUGH THE USER STATED THAT IT DIDN'T APPEAR THAT THE PATIENT WAS GETTING LARGER TIDAL VOLUMES FROM THIS VENTILATOR THAN THE OTHER ONE. THE PATIENT FELT SIMILARLY WITH BOTH VENTILATORS. THERE WAS NO HARM TO THE PATIENT. THE PATIENT WAS ALERT, COMFORTABLE, AND RESPONSIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21662877 ↗
• MalfunctionFeb 24, 2025Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE NKV-330 TOUCHSCREEN HAD GONE BLACK DURING PATIENT USE. THE VENTILATOR CONTINUED VENTILATING THE PATIENT, AND THE PATIENT WAS UNAFFECTED. THE PATIENT WAS PLACED ON ANOTHER VENTILATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21453119 ↗
• MalfunctionJan 23, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE USER PLACED THE PATIENT ON THE NKV-330 VENTILATOR WITH A FIO2 SETTING OF 100%, AND THE VENTILATOR READ A MEASURED FIO2 IN THE 80S. THERE WAS A MINIMAL LEAK AND ADEQUATE TIDAL VOLUMES, YET THE VENTILATOR CONTINUED TO ALARM 'LOW FIO2'. THE PATIENT WAS PLACED ON ANOTHER VENTILATOR. THERE WAS NO REPORTED HARM TO THE PATIENT. NO PATIENT INFORMATION WILL BE SHARED. A REVIEW OF THE VENTILATOR LOGS SHOWED THERE WAS NO 'LOW FIO2' ALARM RECORDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21222548 ↗
• MalfunctionJan 23, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS PLACED ON THE NKV-330 VENTILATOR. THE PATIENT WAS INITIALLY SET ON A FIO2 OF 50%. THE USER NOTICED THAT SPO2 WAS DECREASING INTO THE 80¿S AND THEY INCREASED THE SET FIO2 TO 100%. AFTER A FEW MOMENTS, THE VENTILATOR STARTED TO ALARM 'LOW FIO2'. THE USER TRIED MULTIPLE VENTILATOR SETTINGS TO CLEAR THE LOW FIO2 ALARM AND WAS UNSUCCESSFUL. THE USER TRIED ANOTHER OXYGEN SOURCE, BUT THE 'LOW FIO2' ALARM WAS STILL PRESENT. THE PATIENT'S SPO2 CONTINUED TO DECREASE, SO THE THERAPIST REMOVED THE PATIENT FROM THE VENTILATOR AND PLACED THE PATIENT ON ANOTHER VENTILATOR. THE PATIENT'S SPO2 BEGAN TO INCREASE UP TO 100%. THERE WAS NO REPORTED HARM TO THE PATIENT.

  Patient problems: Low Oxygen Saturation

  MAUDE report 21222510 ↗
• MalfunctionJan 9, 2025Low Readings; Low Readings

  PER THE MED SUN REPORT THAT NKOM RECEIVED ON (B)(6)2024, THE RESPIRATORY THERAPIST (RT) ATTEMPTED TO USE THE NKV-330 VENTILATOR ON A PATIENT WHO COULD POSSIBLY NEED BIPAP FOLLOWING HEATED HIGH FLOW. RT APPROPRIATELY ASSEMBLED THE VENTILATOR FOR HIGH FLOW, PLUGGED IT IN, AND SET SETTINGS TO MIRROR ANOTHER DEVICE WITH 60 LPM/95% FIO2 SETTINGS. THE RT SET THE FIO2 HIGHER AT 100% TO MEET THE PATIENT'S OXYGEN DEMAND. HOWEVER, THE LOW OXYGEN ALARM WAS TRIGGERED DUE TO THE OXYGEN FIO2 FEEDBACK READING 88-93% FIO2, NOT THE SET 100%. THE RT THEN PLACED THE PATIENT ON ANOTHER DEVICE. ACCORDING TO THE MEDICAL RECORD, THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21113952 ↗
• MalfunctionDec 26, 2024Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT THE RESPIRATORY THERAPIST (RT) PERFORMED A CIRCUIT CHECK AND O2 CALIBRATION AND ENSURED THEY BOTH PASSED ON THE NKV-330 VENTILATOR WHILE SETTING UP THE VENTILATOR FOR PATIENT USE DURING A RAPID RESPONSE. DEFAULT SETTINGS ON NKV-330 WERE MODE: S/T, IPAP: 10, EPAP 5, AND FIO2 21%. THE RT ADJUSTED SETTINGS TO S/T IPAP 14, EPAP 8, AND 60% FIO2. THE RT PRESSED START VENTILATION. THE VENTILATOR BEGAN ALARMING AND SHOWING ALARM MESSAGES (IN ORDER) TECHNICAL FAULT 00011, VENT INOP. 00006, AND CHECK PROX. PRESSURE LINE. THE RT DID NOT PLACE THE PATIENT ON THE NKV-330 VENTILATOR; INSTEAD, THE PATIENT WAS PLACED ON ANOTHER VENTILATOR. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21021473 ↗
• MalfunctionDec 26, 2024Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT PRIOR TO PATIENT USE WHEN THE USER SWITCHED THE NKV-330 VENTILATOR FROM STANDBY TO VENTILATION MODE, IT ALARMED TECHNICAL FAULT 00011 AND VENT INOP 00006. THE PATIENT WAS NOT PLACED ON THIS VENTILATOR AND WAS PLACED ON ANOTHER VENTILATOR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21021457 ↗
• MalfunctionDec 10, 2024Defective Component; Defective Component

  IT WAS REPORTED THAT THE NKV-330 VENTILATOR BLOWER WAS MAKING A LOUD NOISE DURING PATIENT USE. THE VENTILATOR CONTINUED VENTILATING THE PATIENT, AND THE PATIENT WAS PLACED ON ANOTHER VENTILATOR. THERE WAS NO PATIENT HARM OR INJURY. BIOMED CONFIRMED THAT THE FAN MOTOR SOUND WAS LOUD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20894161 ↗
• MalfunctionDec 10, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PRIOR TO THE RESPIRATORY THERAPIST CONNECTING THE PATIENT TO THE NKV-330 VENTILATOR, THE VENTILATOR DISPLAYED A "LOW FIO2" WITH A TECHNICAL FAULT 00006 ALARM MESSAGE. THE PATIENT WAS NOT PLACED ON THIS VENTILATOR AND WAS PLACED ON ANOTHER VENTILATOR. THERE WAS NO PATIENT INJURY. THE VENTILATOR WAS BROUGHT TO THE BIOMED DEPARTMENT FOR TESTING AND VERIFICATION. CLINICAL ENGINEERING VERIFIED THE ERROR MESSAGE USING A TEST LUNG, OPENED BDU TO INSPECT VISUALLY, FOUND NOTHING WRONG, AND REASSEMBLED. THE VENTILATOR WAS NO LONGER ALARMING, BUT THE EVENT LOG SHOWED THE ERROR MESSAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20894127 ↗
• MalfunctionDec 10, 2024Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT BEFORE CONNECTING THE PATIENT TO THE NKV-330 VENTILATOR, THE VENTILATOR DISPLAYED A 'VENT INOP' ALARM MESSAGE. THERE WAS NO PATIENT INJURY, AND THE PATIENT WAS PLACED ON ANOTHER VENTILATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20894113 ↗