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NA GF-210R (REF GF-210RA)Recalls & reported problems

Nihon Kohden America, Inc. · Multi-Gas Module · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841983100321), received between Jun 28, 2019 and Aug 29, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Communication or Transmission Problem1
  • Data Problem1
  • Loss of Data1
  • Output Problem1
  • Unable to Obtain Readings1
  • Wireless Communication Problem1

Patient problems

  • No Known Impact Or Consequence To Patient2
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 29, 2019Unable to Obtain Readings; Communication or Transmission Problem; Output Problem; Wireless Communication Problem; Unable to Obtain Readings; Communication or Transmission Problem; Output Problem; Wireless Communication Problem

    THE BIOMEDICAL ENGINEER REPORTED THAT THE MULTIGAS UNIT GAVE A "DEVICE ERROR" MESSAGE.

    Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

    MAUDE report 8947877 ↗
  • MalfunctionJun 28, 2019Loss of Data; Data Problem; Loss of Data; Data Problem

    THE BIOMEDICAL ENGINEER REPORTED THAT THE MULTIGAS UNIT WAS DROPPING PATIENT DATA INTERMITTENTLY DURING CASES.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8746618 ↗

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Sources and updates

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