3100A HFOV 29028-003Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 50190752159745), received between Nov 17, 2021 and Aug 1, 2022 — classified as 6 injuries.

The most frequently reported specific device problem is “Disconnection” (3 reports).

1 other recall cover devices cleared under the same FDA submission (P890057); 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryAug 1, 2022Disconnection; Disconnection

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE SECURE CONNECTIONS ON THE WET SIDE OF THE 29028-003 BOXED PATIENT CIRCUIT ASSY, 3100A, 850S DISCONNECTED WHILE A PATIENT WAS ATTACHED AND BEING VENTILATED. THIS CAUSED LOSS OF PRESSURE AND STOPPED DELIVERY. END USER MANUALLY VENTILATED THE PATIENT UNTIL THE CIRCUIT WAS CHANGED.THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15141951 ↗
• InjuryAug 1, 2022Disconnection; Disconnection

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE SECURE CONNECTIONS ON THE WET SIDE OF THE 29028-003 BOXED PATIENT CIRCUIT ASSY, 3100A, 850S DISCONNECTED WHILE A PATIENT WAS ATTACHED AND BEING VENTILATED. THIS CAUSED LOSS OF PRESSURE AND STOPPED DELIVERY. END USER MANUALLY VENTILATED THE PATIENT UNTIL THE CIRCUIT WAS CHANGED.THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15141840 ↗
• InjuryJul 29, 2022Disconnection; Disconnection

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE SECURE CONNECTIONS ON THE WET SIDE OF THE 29028-003 BOXED PATIENT CIRCUIT ASSY, 3100A, 850'S DISCONNECTED WHILE A PATIENT WAS ATTACHED AND BEING VENTILATED. THIS CAUSED LOSS OF PRESSURE AND STOPPED DELIVERY. END USER MANUALLY VENTILATED THE PATIENT UNTIL THE CIRCUIT WAS CHANGED. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15136454 ↗
• InjuryNov 17, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  THE CUSTOMER REPORTED THAT THE BOXED PATIENT CIRCUIT ASSY, 3100A, 850S (HOSE) CAME LOOSE FROM THE COUPLING PIECE THAT CONNECTS BACK TO THE HUMIDIFICATION CHAMBER OF THE F&P. AS SUCH, THE HFO (HIGH FREQUENCY OSCILLATION) STOPPED. THE HOSE WAS REINSERTED, FIXED WITH BROWN TAPE, AND SECURED WITH COUPLER AND TIE WRAP. IT HAPPENED DURING PATIENT USE BUT WITH NO INFORMATION REGARDING OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12833197 ↗
• InjuryNov 17, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  THE CUSTOMER REPORTED THAT THE BOXED PATIENT CIRCUIT ASSY, 3100A, 850S (HOSE) CAME LOOSE FROM THE COUPLING PIECE THAT CONNECTS BACK TO THE HUMIDIFICATION CHAMBER OF THE F&P. AS SUCH, THE HFO (HIGH FREQUENCY OSCILLATION) STOPPED. THE HOSE WAS REINSERTED, FIXED WITH BROWN TAPE, AND SECURED WITH COUPLER AND TIE WRAP. IT HAPPENED DURING PATIENT USE BUT WITH NO INFORMATION REGARDING OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12833147 ↗
• InjuryNov 17, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  THE CUSTOMER REPORTED THAT THE BOXED PATIENT CIRCUIT ASSY, 3100A, 850S (HOSE) CAME LOOSE FROM THE COUPLING PIECE THAT CONNECTS BACK TO THE HUMIDIFICATION CHAMBER OF THE F&P. AS SUCH, THE HFO (HIGH FREQUENCY OSCILLATION) STOPPED, AND THE PATIENT EXPERIENCED DESATURATED, DROP IN CARDIAC ACTIVITY, AND SYSTOLE. THE END USER PROVIDED VENTILATION WITH HOOD AND BALLOON AS WELL AS CHEST COMPRESSIONS (20 TIMES), AND THE PATIENT RECOVERED. THE HOSE WAS REINSERTED, FIXED WITH BROWN TAPE, AND SECURED WITH COUPLER AND TIE WRAP.

  Patient problems: Low Oxygen Saturation

  MAUDE report 12829830 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P890057. One submission often covers many models, so check the product and lot details in each record.

• Z-0488-2024 · Oct 27, 2023 · Completed
  vyaire Flexible Patient Circuit, 3100A, REF 29028-003, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)