NA AG-920RARecalls & reported problems
Nihon Kohden America, Inc. · MULTI GAS UNIT · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Nihon Kohden multi-gas unit monitors carbon dioxide and other gases during anesthesia and respiratory care. The 41 reports mostly describe the unit showing gas readings that are too low or otherwise inaccurate, along with calibration error messages appearing during patient use. No deaths or injuries are described, and most reports note no effect on the patient. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 41
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00841983103162), received between Jan 11, 2017 and Apr 23, 2020 — classified as 41 malfunctions.
The most frequently reported specific device problem is “Output Problem” (18 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.
Most reported problems
Device problems
- Output Problem18
- Incorrect, Inadequate or Imprecise Result or Readings14
- Incorrect Measurement5
- Device Operates Differently Than Expected4
- Low Readings4
- Calibration Problem3
- Device Displays Incorrect Message3
- Device Operational Issue3
Patient problems
- No Known Impact Or Consequence To Patient37
- No Consequences Or Impact To Patient6
- No Clinical Signs, Symptoms or Conditions5
- No Information1
Recent adverse event reports
The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 23, 2020Output Problem; Output Problem
THE CUSTOMER REPORTED THAT THE MULTIGAS UNIT IS DISPLAYING LOWER GAS VALUES THAN THEY SHOULD BE. NO ERRORS GENERATED.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 9993183 ↗MalfunctionFeb 20, 2020Gas Output Problem; Output Problem; Gas Output Problem; Output Problem
THE CUSTOMER REPORTED THAT THE MULTI-GAS UNIT WAS SHOWING LOW GAS READINGS WHILE IN PATIENT USE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9734943 ↗MalfunctionJan 23, 2020Output Problem; Output Problem
THE CUSTOMER REPORTED THAT THE MULTIGAS UNIT GAVE A "GAS CAL" ERROR MESSAGE DURING A CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 9624720 ↗MalfunctionJan 3, 2020Display or Visual Feedback Problem; Application Program Problem: Dose Calculation Error; Output Problem; Display or Visual Feedback Problem; Application Program Problem: Dose Calculation Error; Output Problem
THE CUSTOMER REPORTED THAT THEIR MULTI-GAS UNIT WAS DISPLAYING "CAL ERROR" ALARMS. THE DEVICE ALSO DISPLAYED "GAS UNSPECIFIED ACCURACY," AND THE CUSTOMER REPORTED THE CO2 READING TO BE ABOUT HALF OF WHAT IT SHOULD HAVE BEEN.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 9547100 ↗MalfunctionDec 13, 2019Output Problem; Output Problem
THE CUSTOMER REPORTED THAT THEIR MULTI-GAS UNIT WAS DISPLAYING LOW CO2 READINGS DURING A CASE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9470248 ↗MalfunctionDec 13, 2019Output Problem; Output Problem
THE CUSTOMER REPORTED THAT THE MULTI-GAS UNIT GAVE A "GAS CAL" ERROR MESSAGE DURING A CASE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9470247 ↗MalfunctionDec 5, 2019Calibration Problem; Calibration Problem
THE CUSTOMER REPORTED THAT THE MULTIGAS UNIT DISPLAYED A "CALIBRATION" ERROR WHILE IN PATIENT USE.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 9419824 ↗MalfunctionDec 5, 2019Calibration Problem; Calibration Problem
THE CUSTOMER REPORTED THAT THE MULTIGAS UNIT DISPLAYED "CALIBRATION" ERROR WHILE IN PATIENT USE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9419823 ↗MalfunctionNov 11, 2019Gas Output Problem; No Device Output; Gas Output Problem; No Device Output
THE CUSTOMER REPORTED THAT THE MULTI-GAS UNIT FAILED DURING PATIENT MONITORING. THE DEVICE DISPLAYED ERROR MESSAGES SUCH AS, "CHECK WATER TRAP AND SAMPLE LINE" AND "CHECK EXTERNAL UNIT." NO PATIENT HARM WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9307259 ↗MalfunctionNov 8, 2019Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem
THE CUSTOMER REPORTED THAT THE MULTI-GAS UNIT GAVE INACCURATE CO2 READINGS. NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 9300115 ↗MalfunctionNov 8, 2019Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem
THE CUSTOMER REPORTED THAT THE MULTI-GAS UNIT GAVE INACCURATE CO2 READINGS. NO PATIENT HARM REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9300111 ↗MalfunctionSep 14, 2019Device Displays Incorrect Message; Output Problem; Device Displays Incorrect Message; Output Problem
THE CUSTOMER REPORTED THAT THE MULTI-GAS UNIT IS CONSTANTLY DISPLAYING "CHECK WATER TRAP" ERROR MESSAGE EVEN AFTER SWAPPING OUT DRY LINES AND WATER TRAPS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9056731 ↗MalfunctionJun 13, 2019Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTI-GAS UNIT GAVE INACCURATE CO2 BASELINE READINGS. CO2 WAS WAY ABOVE 0, ABOUT 4%. IT LOOKED LIKE A BAND OF INTERFERENCE AT THE BOTTOM OF THE WAVEFORM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8697757 ↗MalfunctionMay 6, 2019Low Readings; Low Readings
THE CUSTOMER REPORTED THAT THE MULTI-GAS UNIT IS GIVING INCORRECT READINGS THAT ARE TOO LOW DURING A CASE. NO CONSEQUENCE OR IMPACT TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8584766 ↗MalfunctionApr 12, 2019Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem
THE CUSTOMER REPORTED THAT THE MULTI-GAS UNIT IS NOT GIVING ACCURATE GAS READINGS. NO CONSEQUENCE OR IMPACT TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 8509494 ↗MalfunctionMar 29, 2019Low Readings; Low Readings
THE CUSTOMER REPORTED THAT THE MULTI-GAS UNIT IS GIVING INCORRECT READINGS THAT ARE TOO LOW AND THE UNIT WAS UNABLE TO BE CALIBRATED. NO CONSEQUENCE OR IMPACT TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8466343 ↗MalfunctionFeb 28, 2019Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem
THE BIOMEDICAL ENGINEER REPORTED THAT THE THE MULTIGAS UNIT DISPLAYED A "SELECT GAS NOT SPECIFIC" ERROR MESSAGE AND WOULD NOT DISPLAY ACCURATE CO2 VALUES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8380512 ↗MalfunctionNov 8, 2018Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIGAS UNIT WAS GIVING INACCURATE READINGS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8053497 ↗MalfunctionOct 18, 2018Unable to Obtain Readings; Output Problem; Unable to Obtain Readings; Output Problem
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIGAS UNIT INTERMITTENTLY STOPPED GIVING GAS READINGS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7982433 ↗MalfunctionOct 9, 2018Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED THAT THE MULTI-GAS UNIT IS GIVING INCORRECT READINGS WHILE ON A PATIENT. NO CONSEQUENCE OR IMPACT TO PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7947947 ↗MalfunctionSep 12, 2018Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT, DURING A CASE, THE MULTIGAS UNIT HAD INACCURATE ETCO2 AND SEVO VALUES. IT ALSO GAVE A CALIBRATION ERROR MESSAGE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7871306 ↗MalfunctionSep 12, 2018Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIGAS UNIT GAVE INACCURATE READINGS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7871301 ↗MalfunctionSep 11, 2018Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED THAT THE MULTI-GAS UNIT IS NOT GIVING ACCURATE READINGS. THE CUSTOMER TRIED REPLACING THE WATER TRAP, SAMPLING LINE, AND ALSO PERFORMED CALIBRATION; HOWEVER, THE DEVICE STILL GIVES INACCURATE READINGS. THE CUSTOMER STATED THEY WILL RETURN THE DEVICE FOR EVALUATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7866456 ↗MalfunctionAug 16, 2018Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTS THAT THE MULTI GAS UNIT IS NOT TAKING AN ACCURATE READING. THE DEVICE IS RUNNING LOUDER THAN USUAL AND GIVING A CALIBRATION ERROR WHEN CONNECTED TO THE BEDSIDE MONITOR.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7789700 ↗MalfunctionAug 9, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED THAT THE READINGS ON THE MULTI GAS UNIT ARE FLUCTUATING WHEN IN PATIENT USE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7770901 ↗
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- NA GF-210RNihon Kohden Corporation · ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE386 reports
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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