3100A HFOV 11518-850S (UDI 10846446003192)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10846446003192), received between Nov 6, 2020 and Jul 19, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 19, 2022Product Quality Problem; Product Quality Problem

  THE CUSTOMER REPORTED THAT THE PATIENT'S CO2 WENT UP TO 12 AND THEN 20 EVEN THOUGH THE OSCILLATOR WAS ABLE TO OXYGENATE THE PATIENT, AND THIS COULD NOT BE CLEARED ON LOWER FREQUENCY OR INCREASED AMPLITUDE. ALSO, THERE WERE SEVERE "RAINOUTS" OR COPIOUS AMOUNTS OF WATER IN WATER TRAP, TUBING AND FILTERS. THE MAP WAS FLUCTUATING, CAUSING PATIENT TO DESATURATE. END USERS IMMEDIATELY ATTENDED TO THE PATIENT AND MADE THE SITUATION SAFE BY CLEARING CONDENSATION FROM THE SYSTEM (WATER TRAP REQUIRED EMPTYING TWICE IN 4 HOURS), CHANGING TO A DIFFERENT OSCILLATOR WITHOUT A FILTER, OR PUTTING THE PATIENT BACK ONTO CONVENTIONAL VENTILATION. THE ISSUE HAVE OCCURRED MULTIPLE TIMES ((B)(4)) ON DIFFERENT OSCILLATORS. HOWEVER, CURRENT OPINION OF THE END USERS IS THAT IT COULD BE RELATED TO THE BOXED PATIENT CIRCUIT ASSY, 31A, FILTERED, 850S AS NO NOTICEABLE PROBLEM WITH OLD PATIENT SETS (NO FILTER). CO2 - CARBON DIOXIDE. MAP - MEAN AIRWAY PRESSURE.

  Patient problems: Hypoventilation; Low Oxygen Saturation

  MAUDE report 15059691 ↗
• MalfunctionMay 6, 2022Loose or Intermittent Connection; Loose or Intermittent Connection

  THE CUSTOMER REPORTED THAT THE BIAS GAS TUBE WITH CONNECTED FROM THE WATER CHAMBER TO THE 11518-850S BOXED PATIENT CIRCUIT ASSY,31A, FILTERED,850S HAS A WEAK POINT AND BECOMES LOOSE AFTER A FEW HOURS OF USE, WHICH CAUSES PRESSURE TO DROP AND THE OSCILLATOR TO STOP. THERE IS NO INFORMATION ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14307973 ↗
• InjuryNov 6, 2020Thermal Decomposition of Device; Thermal Decomposition of Device

  THE CUSTOMER REPORTED THAT THE NURSE OBSERVED A CHANGE OF COLOR OF THE HEATING WIRE INSIDE THE BOXED PATIENT CIRCUIT ASSY, 31A,FILTERED,850S . THE ISSUE OCCURRED DURING PATIENT-USE AND THE CIRCUIT WAS REPLACED. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10804891 ↗