Digital Ultra Flushmount Package H CHAIR 56800-CHAIRRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00813830024258), received between Nov 17, 2023 and Dec 8, 2023 — classified as 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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 8, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE INVOLVING THE DIGITAL ULTRA FLUSHMOUNT FLOWMETER, THE PATIENTS O2 SATURATION BEGAN TO DROP. THE PROCEDURE WAS STOPPED AND MEDICAL INTERVENTION WAS ADMINISTERED.

  Patient problems: Low Oxygen Saturation

  MAUDE report 18290959 ↗
• MalfunctionNov 17, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE USER FACILITY REPORTED THAT PATIENTS FELT TEMPORARILY DISORIENTED DURING PROCEDURES INVOLVING THE ACCUTRON DIGITAL ULTRA FLOWMETER. THE REPORTED EVENT WAS CONFIRMED TO OCCUR ON FOUR SEPARATE DATES.

  Patient problems: Insufficient Information

  MAUDE report 18159218 ↗

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-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-0019-2013 · Apr 29, 2012 · Terminated
  CM Flowmeter Pkg H, Model #36700, Serial # 13749 Product Usage: Conscious Sedation Unit Analgesia Gas Machine.