NA AY-653PRecalls & reported problems
Nihon Kohden Corporation · Input unit, 3 MULTI connector, Nellcor SpO2 · Class 2
- 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 04931921101513), received between Jan 7, 2025 and Jan 7, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Patient Data Problem” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Patient Data Problem1
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.
MalfunctionJan 7, 2025Patient Data Problem; Patient Data Problem
THE CUSTOMER REPORTED THAT THE AY INPUT UNIT CONNECTED TO THE BEDSIDE MONITOR (BSM) WAS NOT TAKING BLOOD PRESSURE AND ELECTROCARDIOGRAM (ECG) READINGS WHILE IT WAS HOOKED UP TO A PATIENT. NO PATIENT HARM OR INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21097758 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.