Newport Flowmeter System 50000Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00813830023305), received between Dec 7, 2022 and Dec 7, 2022 — classified as 1 malfunction.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT DURING PATIENT PROCEDURES INVOLVING THE NEWPORT FLOWMETER PATIENTS BECAME NAUSEOUS AND SOME BEGAN TO VOMIT. THE PATIENTS WERE ADMINISTERED OXYGEN AND FULLY RECOVERED. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Nausea; Vomiting

  MAUDE report 15933120 ↗

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-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
• 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