F&P Evaqua 2 RT385Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 09420012430472), received between Jun 6, 2017 and Dec 4, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2025Disconnection; Disconnection

  A HEALTHCARE FACILITY IN CHINA REPORTED THAT, DURING PATIENT USE, A VENTILATOR ALARMED FOR "DISCONNECTION OF THE TUBING" OF AN RT385 ADULT VENTILATOR CIRCUIT DUAL HEATED WITH EVAQUA TECHNOLOGY. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: Hypoxia

  MAUDE report 23720845 ↗
• MalfunctionFeb 10, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A HEALTHCARE FACILITY IN CHINA REPORTED THAT AN RT385 ADULT VENTILATOR CIRCUIT DUAL HEATED WITH EVAQUA TECHNOLOGY WAS FOUND CRACKED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21351853 ↗
• MalfunctionDec 26, 2024Leak/Splash; Leak/Splash

  AA HEALTHCARE FACILITY IN CHINA REPORTED THAT AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER PROVIDED WITH AN RT385 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT WAS FOUND LEAKING WATER DURING USE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21023281 ↗
• MalfunctionNov 28, 2024Gas/Air Leak; Gas/Air Leak

  A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT AN RT385 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT FAILED THE VENTILATOR LEAK TEST PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20808065 ↗
• MalfunctionNov 21, 2024Mechanical Problem; Mechanical Problem

  A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT THE EXPIRATORY TUBE OF AN RT385 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT WAS FOUND DAMAGED DURING PATIENT USE. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20754042 ↗
• MalfunctionNov 20, 2023Fluid/Blood Leak; Fluid/Blood Leak

  A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT A MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER PROVIDED WITH RT385 ADULT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT WAS FOUND LEAKING WATER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18179371 ↗
• MalfunctionOct 8, 2023Fluid/Blood Leak; Fluid/Blood Leak

  A HEALTHCARE FACILITY IN BRAZIL REPORTED VIA A FISHER AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT A MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS FOUND LEAKING WATER DURING PATIENT USE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17892703 ↗
• MalfunctionDec 15, 2022Leak/Splash; Leak/Splash

  A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN JAPAN, THAT A RT385 ADULT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT FAILED THE VENTILATOR LEAK TEST BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15992879 ↗
• MalfunctionMay 26, 2022Gas/Air Leak; Therapeutic or Diagnostic Output Failure; Gas/Air Leak

  A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN JAPAN VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT A RT385 ADULT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT FAILED THE VENTILATOR LEAK TEST BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14504861 ↗
• MalfunctionJun 6, 2017Break; Device Operates Differently Than Expected

  A HOSPITAL IN (B)(6) REPORTED VIA A FISHER AND PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT THE RT385 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT FAILED THE INITIAL VENTILATOR LEAK TEST. THE EXPIRATORY LIMB OF THE RT385 CIRCUIT WAS FOUND DAMAGED. THIS WAS FOUND BEFORE USE ON A PATIENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 6613713 ↗