F&P Evaqua 2 RT380Recalls & reported problems

Summary

The FDA's MAUDE database contains 305 adverse event reports that list this exact device (DI 09420012429728), received between Apr 13, 2017 and Aug 3, 2026 — classified as 1 injury, 304 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (120 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 25 most recent of 305 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 3, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50111191 ↗
• MalfunctionJun 8, 2026Material Puncture/Hole; Gas/Air Leak

  A HEALTHCARE FACILITY IN CHINA REPORTED VIA A FISHER & PAYKEL (F&P) HEALTHCARE FIELD REPRESENTATIVE THAT THE RT380 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT FAILED THE PRE-USE LEAK TEST. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25436643 ↗
• MalfunctionMay 24, 2026Loose or Intermittent Connection

  A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN JAPAN THAT AN RT380 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT WAS FOUND TO HAVE A LOOSE CONNECTOR BEFORE PATIENT USE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25267250 ↗
• MalfunctionMay 17, 2026Gas/Air Leak

  A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN JAPAN THAT AN RT380 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT FAILED THE VENTILATOR LEAK TEST PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25196844 ↗
• MalfunctionApr 29, 2026Fluid/Blood Leak

  A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER PROVIDED WITH AN RT380 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT WAS FOUND LEAKING WATER AFTER 12 HOURS OF PATIENT USE. THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25038440 ↗
• MalfunctionApr 29, 2026Fluid/Blood Leak

  A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA, THAT THE MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER PROVIDED WITH AN RT380 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT WAS FOUND LEAKING WATER FROM THE CHAMBER BASE AFTER ONE DAY OF PATIENT USE. THERE WERE NO REPORTED PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25038212 ↗
• MalfunctionApr 28, 2026Crack; Leak/Splash

  A HEALTHCARE FACILITY IN CHINA REPORTED VIA A FISHER & PAYKEL (F&P) HEALTHCARE FIELD REPRESENTATIVE, THAT AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER PROVIDED AS PART OF THE RT380 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT WAS LEAKING WATER FROM THE HUMIDIFICATION CHAMBER DURING PATIENT USE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25024203 ↗
• MalfunctionApr 21, 2026Fluid/Blood Leak

  A DISTRIBUTOR IN CHINA REPORTED ON BEHALF OF A HEALTHCARE FACILITY VIA A FISHER & PAYKEL (F&P) HEALTHCARE FIELD REPRESENTATIVE THAT TWO MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS PROVIDED WITH AN RT380 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT WAS FOUND LEAKING WATER BETWEEN THE CHAMBER DOME AND BASE. THERE WERE NO REPORTED PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24948386 ↗
• MalfunctionApr 21, 2026Fluid/Blood Leak

  A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER PROVIDED AS A PART OF AN RT380 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT WAS LEAKING WATER DURING SETUP, PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24944949 ↗
• MalfunctionApr 13, 2026Fluid/Blood Leak

  A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA, THAT AN MR290V AUTOFEED HUMIDIFCATION CHAMBER PROVIDED AS PART OF A RT380 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT WAS FOUND LEAKING WATER FROM THE CHAMBER DURING PATIENT USE. THERE WAS NO REPORTED PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24867873 ↗
• MalfunctionApr 13, 2026Fluid/Blood Leak

  A DISTIRBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAN AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER PROVIDED WITH AN RT380 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT WAS FOUND LEAKING WATER FROM THE CHAMBER BEFORE PATIENT USE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24867690 ↗
• MalfunctionApr 13, 2026Fluid/Blood Leak

  A HEALTHCARE FACILITY IN CHINA REPORTED VIA A DISTRIBUTOR THAT AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER PROVIDED AS PART OF THE RT380 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT WAS FOUND LEAKING WATER DURING USE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24867651 ↗
• MalfunctionMar 30, 2026Fluid/Blood Leak

  A HEALTHCARE FACILITY IN CHINA REPORTED THAT AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER PROVIDED AS A PART OF AN RT380 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT WAS FOUND LEAKING WATER FROM THE CHAMBER BASE DURING USE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24735517 ↗
• MalfunctionMar 26, 2026Crack

  A DISTRIBUTOR IN CHINA REPORTED ON BEHALF OF A HEALTHCARE FACILITY THAT AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER PROVIDED WITH AN RT380 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT WAS FOUND CRACKED. THERE WAS NO PATIENT INVOLVEMENT AS THE ISSUE WAS FOUND WHILST THE DEVICE WAS NOT IN USE ON A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24706254 ↗
• MalfunctionMar 15, 2026Fluid/Blood Leak

  A HEALTHCARE FACILITY IN CHINA REPORTED THAT AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER PROVIDED WITH AN RT380 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT WAS FOUND LEAKING WATER. THERE WERE NO REPORTED PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24602111 ↗
• MalfunctionMar 15, 2026Crack

  A DISTRIBUTOR IN JAPAN REPORTED ON BEHALF OF A HEALTHCARE FACILITY THAT TWO RT380 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUITS WERE FOUND WITH A CRACK ON THE EXPIRATORY LIMB. THE DISTRIBUTOR ALSO REPORTED THAT THE SUBJECT CIRCUITS WERE IN USE FOR APPROXIMATELY ONE MONTH. THERE WERE NO REPORTED PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24602105 ↗
• MalfunctionMar 2, 2026Fluid/Blood Leak

  A DISTRIBUTOR IN CHINA REPORTED ON BEHALF OF A HEALTHCARE FACILITY THAT AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER PROVIDED WITH AN RT380 ADULT VENTILATOR CIRCUIT WAS FOUND LEAKING WATER. THERE WAS NO PATIENT INVOLVEMENT AS THE ISSUE WAS FOUND WHILST THE DEVICE WAS NOT IN USE ON A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24480067 ↗
• MalfunctionFeb 15, 2026Fluid/Blood Leak

  A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER PROVIDED AS A PART OF AN RT380 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT WAS LEAKING WATER AFTER 10 MINUTES OF PATIENT USE. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24341696 ↗
• MalfunctionFeb 15, 2026Crack; Gas/Air Leak

  A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN JAPAN THAT AN RT380 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT FAILED THE PRE-USE VENTILATOR LEAK TEST DURING SETUP AND PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24341695 ↗
• MalfunctionFeb 10, 2026Gas/Air Leak

  A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN JAPAN, VIA A FISHER & PAYKEL (F&P) HEALTHCARE FIELD REPRESENTATIVE, THAT AN RT380 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT FAILED THE VENTILATOR LEAK TEST PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24310505 ↗
• MalfunctionFeb 2, 2026Crack; Gas/Air Leak

  A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN JAPAN, VIA A FISHER & PAYKEL (F&P) HEALTHCARE FIELD REPRESENTATIVE, THAT AN RT380 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT FAILED THE VENTILATOR LEAK TEST DURING SET UP AND BEFORE PATIENT USE. UPON INSPECTION, A CRACK WAS IDENTIFIED ON THE MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER THAT WAS PROVIDED WITH THE RT380 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24242875 ↗
• MalfunctionFeb 2, 2026Crack; Fluid/Blood Leak

  A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER PROVIDED WITH AN RT380 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT WAS FOUND LEAKING WATER FROM CRACKS ON THE CHAMBER DOME AFTER 6 DAYS OF USE. THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24242872 ↗
• MalfunctionFeb 2, 2026Gas/Air Leak

  A HEALTHCARE FACILITY IN SWEDEN REPORTED VIA A FISHER & PAYKEL (F&P) HEALTHCARE FIELD REPRESENTATIVE THAT AN RT380 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT FAILED THE VENTILATOR LEAK TEST PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24242871 ↗
• MalfunctionJan 20, 2026Mechanical Problem; Gas/Air Leak

  A HEALTHCARE FACILITY IN ITALY REPORTED THAT AN RT380 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT FAILED THE VENTILATOR LEAK TEST PRIOR TO PATIENT USE. THE HEALTHCARE FACILITY FURTHER REPORTED THAT THE EXPIRATORY TUBING IS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24126506 ↗
• MalfunctionJan 19, 2026Fluid/Blood Leak

  A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN JAPAN, VIA A FISHER & PAYKEL (F&P) HEALTHCARE FIELD REPRESENTATIVE, THAT AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER PROVIDED WITH AN RT380 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT WAS FOUND LEAKING WATER DURING PATIENT USE. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24110628 ↗