Automatic Manifold, Digi-Flo 27497-FRURecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00813830027747), received between May 19, 2023 and May 19, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Gas Output Problem” (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 18, 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.

• MalfunctionMay 19, 2023Gas Output Problem; Gas Output Problem

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE INVOLVING THE DIGI-FLO AUTOMATIC MANIFOLD, A PATIENT'S EYES ROLLED AND MUSCLE CONVULSION WAS OBSERVED. THE MASK WAS REMOVED FROM THE PATIENT AND THE PATIENT REGAINED CONSCIOUSNESS. THE PATIENT IS REPORTED TO BE FULLY RECOVERED AND THERE WAS NO ADDITIONAL MEDICAL INTERVENTION REQUIRED FOLLOWING THE EVENT.

  Patient problems: Loss of consciousness

  MAUDE report 16960806 ↗

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-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