Flowmeter, Digital Flushmount 27076Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00813830020885), received between Oct 8, 2020 and Mar 19, 2026 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

4 other recalls cover devices cleared under the same FDA submission (K052335); they may or may not involve this specific model.

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

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMar 19, 2026Insufficient Device Problem Information

  DISTRIBUTOR STATED THAT (B)(6) REPORTED THAT DURING PROCEDURE, THE PATIENT EXPERIENCED DIZZINESS AND NAUSEA. ACCORDING TO THE OPERATOR, EVEN WHEN THE NITROUS OXIDE CONCENTRATION WAS SET TO 0% (OXYGEN-ONLY MODE), THE PATIENT STILL APPEARED TO BE AFFECTED AS IF NITROUS OXIDE WAS BEING DELIVERED.

  Patient problems: Dizziness; Nausea

  MAUDE report 24639176 ↗
• InjuryNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DISTRIBUTOR REPORTED THAT A PATIENT PASSED OUT WITHIN MINUTES OF USING NITROUS. AN AMBULANCE WAS CALLED, AND PATIENT WAS SENT TO THE HOSPITAL. ACCORDING TO HOSPITAL REPORT PATIENT WAS FINE; HAD AN ANXIETY ATTACK.

  Patient problems: Loss of consciousness

  MAUDE report 23485443 ↗
• InjuryAug 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DISTRIBUTOR REPORTED THAT DIGITAL ULTRA IS MAKING PATIENTS SICK.

  Patient problems: Nausea

  MAUDE report 22770442 ↗
• MalfunctionApr 1, 2022Gas Output Problem; Gas Output Problem

  THE USER FACILITY REPORTED THAT DURING TWO SEPARATE PATIENT PROCEDURES INVOLVING THE DIGITAL ULTRA FLUSHMOUNT FLOWMETER, ONE PATIENT BEGAN TO VOMIT AND ANOTHER BECAME UNRESPONSIVE. THE PATIENTS WERE ADMINISTERED OXYGEN AND FULLY RECOVERED.

  Patient problems: Loss of consciousness; Vomiting

  MAUDE report 13981241 ↗
• MalfunctionFeb 2, 2022Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE INVOLVING THE ACCUTRON DIGITAL FLUSHMOUNT FLOWMETER, THE PATIENT BEGAN TO VOMIT AND BECAME UNRESPONSIVE. THE PROCEDURE WAS STOPPED AND MEDICAL INTERVENTIONS WERE ADMINISTERED.

  Patient problems: Loss of consciousness; Vomiting

  MAUDE report 13426088 ↗
• InjuryDec 13, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE USER FACILITY REPORTED THAT DURING USE OF THE DIGITAL FLUSHMOUNT FLOWMETER, MORE NITROUS OXIDE WAS RELEASED THAN INTENDED, WHICH RESULTED IN THE PATIENT TO FEEL NAUSEOUS.

  Patient problems: Oversedation

  MAUDE report 10997532 ↗
• InjuryOct 8, 2020Intermittent Loss of Power; Intermittent Loss of Power

  THE USER FACILITY REPORTED THAT DURING USE OF THE DIGITAL FLUSHMOUNT FLOWMETER WITH 3 PEDIATRIC PATIENTS, MORE NITROUS OXIDE WAS RELEASED THAN INTENDED, WHICH RESULTED IN THE PATIENTS TO FEEL ILL, VOMIT, AND IN RARE EVENTS, PASSING OUT.

  Patient problems: Oversedation

  MAUDE report 10649509 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K052335. One submission often covers many models, so check the product and lot details in each record.

• Z-0020-2013 · Apr 29, 2012 · Terminated
  Newport Portable Package, Model #50000, Serial # 13591, 13592, 13604, 13606, 13614, 13662, 13663, 13664, 13726, 13731, 13733, 13736, 13737, 13738, 13740, 13768, 13770, 13771, 1377
• Z-0019-2013 · Apr 29, 2012 · Terminated
  CM Flowmeter Pkg H, Model #36700, Serial # 13749 Product Usage: Conscious Sedation Unit Analgesia Gas Machine.
• Z-0017-2013 · Apr 29, 2012 · Terminated
  Flow Meter, CM Assembly, Model #27025, Serial # 13686, 13690, 13712, 13793. Flowmeter, CM Assembly, Model#31970, Serial#13692. Product Usage: Conscious Sedation Unit Analgesia
• Z-0018-2013 · Apr 29, 2012 · Terminated
  Ultra PC% Cabinet Mount Package G, Model #36600, Serial # 13593, 13594, 13595, 13596, 13597, 13598, 13599, 13600, 13602, 13605, 13610, 13611, 13612, 13615, 13616, 13617, 13621, 13