NA AY-651PRecalls & reported problems
Nihon Kohden Corporation · Input unit, 1 MULTI connector, Nellcor SpO2 · Class 2
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04931921101506), received between May 15, 2025 and Sep 17, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (2 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings2
- Output Problem2
- Display or Visual Feedback Problem1
- Incorrect Measurement1
- Unable to Obtain Readings1
- Unexpected Shutdown1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 17, 2026Unable to Obtain Readings; Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50808796 ↗MalfunctionApr 23, 2026Incorrect, Inadequate or Imprecise Result or Readings; Output Problem
THE CUSTOMER REPORTED THAT THE NIBP READING ON THIS AY UNIT WAS LOWER THAN THE VALUE DISPLAYED ON THE SIMULATOR. THE ISSUE WAS DISCOVERED DURING PREVENTIVE MAINTENANCE (PM). THE UNIT WAS NOT IN PATIENT USE AT THE TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24967754 ↗MalfunctionAug 5, 2025Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED THAT THE AY INPUT UNIT HAD NON-INVASIVE BLOOD PRESSURE (NIBP) DISCREPANCIES. NO PATIENT HARM OR INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22716003 ↗MalfunctionMay 15, 2025Display or Visual Feedback Problem; Unexpected Shutdown; Display or Visual Feedback Problem; Unexpected Shutdown
THE CUSTOMER REPORTED THAT WHEN THEY TRY TO TAKE A PRESSURE, THE SCREEN GETS A BUNCH OF BLUE BOXES THAT OBSCURE THE SCREEN THEN THE MONITOR SHUTS OFF. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22027383 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.