Flowmeter, Digital Flexmount, Australian 51975-AUSRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00813830025040), received between Apr 24, 2023 and Apr 24, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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.

• MalfunctionApr 24, 2023Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information

  THE USER FACILITY REPORTED VIA VIGILANCE REPORT TO TGA THAT APNOEA OCCURRED DURING A PATIENT PROCEDURE INVOLVING THE DIGITAL ULTRA FLOWMETER. THE PATIENT REQUIRED FIRST AID TREATMENT AND THE EFFECTS WERE REPORTED TO BE TEMPORARY.

  Patient problems: Apnea

  MAUDE report 16794632 ↗

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-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-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-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