Fisher & Paykel Healthcare RT134Recalls & reported problems
Fisher & Paykel Healthcare Limited · Adult Non Heated Dual Watertrap Circuit · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 09420012430533), received between Jul 26, 2017 and Jun 1, 2023 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Leak/Splash4
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Patient Involvement2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 1, 2023Leak/Splash; Leak/Splash
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN JAPAN THAT A RT134 NON-HEATED ADULT BREATHING CIRCUIT FAILED THE VENTILATOR PRE-USE TEST BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17044357 ↗MalfunctionDec 15, 2022Leak/Splash; Leak/Splash
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN JAPAN THAT AN RT134 ADULT BREATHING CIRCUIT DID NOT PASS THE VENTILATOR LEAK TEST BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15992875 ↗MalfunctionJun 10, 2020Leak/Splash; Leak/Splash; Incorrect, Inadequate or Imprecise Result or Readings
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN JAPAN THAT AN RT134 ADULT BREATHING CIRCUIT DID NOT PASS THE VENTILATOR LEAK TEST BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 10141431 ↗MalfunctionJul 26, 2017Leak/Splash; Leak/Splash
A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT AN RT134 ADULT BREATHING CIRCUIT FAILED THE VENTILATOR LEAK TEST. THIS WAS FOUND BEFORE USE ON A PATIENT.
Patient problems: No Patient Involvement
MAUDE report 6746095 ↗
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- HUDSON RCI IPN043837Teleflex Incorporated · SET, TUBING AND SUPPORT, VENTILATOR (W HARNESS)1 recall18 reports
- Breathing circuit set, coaxial 260127Hamilton Medical AG · Set, Tubing And Support, Ventilator (W Harness)1 recall7 reports
- Breathing circuit set, coaxial 260168Hamilton Medical AG · Set, Tubing And Support, Ventilator (W Harness)1 recall4 reports
- Breathing circuit set, coaxial 260167Hamilton Medical AG · Set, Tubing And Support, Ventilator (W Harness)1 recall3 reports
- Vivo Series 006093Breas Medical AB · Set, Tubing And Support, Ventilator (W Harness)1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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