Nihon Kohden NKV-440 (UDI 00843685100159)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00843685100159), received between May 22, 2025 and Sep 29, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Defective Component” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Insufficient Device Problem Information

  Patient problems: Hypoxia

  MAUDE report 50940562 ↗
• MalfunctionJun 24, 2026Use of Device Problem; Failure to Clean Adequately

  IT WAS REPORTED TO NKOM THAT DURING INITIATION OF NEBULIZER TREATMENT, THE VENTILATOR BEGAN GENERATING "CIRCUIT DISCONNECT" AND "CIRCUIT OBSTRUCTION" ALARMS. THE RESPIRATORY THERAPIST (RT) OBSERVED THAT THE DISPLAYED EXHALED TIDAL VOLUME (VTE) AND RESPIRATORY RATE (RR) INTERMITTENTLY FLUCTUATED BETWEEN APPROPRIATE VALUES AND ZERO, DESPITE THE PATIENT CONTINUING TO BREATHE AND TRIGGER THE VENTILATOR. AS A PRECAUTION, THE PATIENT WAS DISCONNECTED FROM THE VENTILATOR AND MANUALLY VENTILATED WITH A RESUSCITATION BAG BEFORE BEING TRANSITIONED TO ANOTHER VENTILATOR. THERE WAS NO PATIENT HARM AS THE PATIENT REMAINED STABLE BEFORE, DURING, AND AFTER THE EVENT. FOLLOW-UP INFORMATION FROM THE RT ON (B)(6) 2026, STATED THAT THE PATIENT RECEIVED DUONEB NEBULIZER TREATMENTS EVERY 6 HOURS AND WAS LAVAGE SUCTIONED AS NEEDED. TROUBLESHOOTING WAS PERFORMED, INCLUDING INSPECTION OF THE PATIENT CIRCUIT FOR DISCONNECTIONS, LEAKS, OR OCCLUSIONS, AND LAVAGE SUCTIONING OF THE PATIENT, WHICH YIELDED AN INSIGNIFICANT AMOUNT OF SECRETIONS. ADDITIONALLY, THE VENTILATOR WAS REPORTED TO EMIT AN INTERMITTENT MOTORIZED OR WHIRRING NOISE. WHEN THE PATIENT WAS PLACED ON ANOTHER VENTILATOR, THE PATIENT TOLERATED TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25615103 ↗
• MalfunctionMay 22, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT THE VENTILATOR DISPLAYED AN ¿INTERNAL AIRFLOW SENSOR FAILURE¿ AND A HIGH FIO2 ALARM WHILE VENTILATING A PATIENT. THE SET FIO2 WAS AT 50%, BUT THE MONITORED VALUE SHOWED FIO2 AT 100%. THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22075428 ↗