NA AY-633PRecalls & reported problems
Nihon Kohden Corporation · Input unit, 3 MULTI connector, Masimo SpO2 · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04931921101490), received between Nov 9, 2022 and Nov 9, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Low Readings” (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 16, 2026.
Most reported problems
Device problems
- Low Readings1
- Output Problem1
- Unable to Obtain Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 9, 2022Unable to Obtain Readings; Low Readings; Output Problem; Unable to Obtain Readings; Low Readings; Output Problem
THE CUSTOMER REPORTED THAT THE AY INPUT UNIT CONNECTED TO THE BEDSIDE MONITOR (BSM) WAS GIVING LOW OR NO SPO2 READINGS. THE NURSES CONFIRMED THE SPO2 READINGS TO BE 10% BELOW NORMAL READINGS. NO PATIENT HARM OR INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15764834 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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