Breathing circuit set, dual limb 260170Recalls & reported problems
Hamilton Medical AG · Dual limb breathing circuit set with Swivel Y-piece, neonatal flow sensor, neonatal expiratory valve set and pressure line for use with HAMILTON-C1/T1/MR1, 150 cm, neonatal, single-use · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630002805902), received between Jan 29, 2024 and Jan 29, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Connection Problem” (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.
Reports received per month
Most reported problems
Device problems
- Connection Problem1
- Fitting Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 29, 2024Fitting Problem; Connection Problem; Fitting Problem; Connection Problem
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: - THIS EVENT WAS REPORTED TO HAMILTON AS THE BREATHING CIRCUIT SET COULD NOT BE CONNECTED TO THE CPAP MASK (FOR CHILDREN). - THIS OCCURRENCE WAS NOTICED WHEN THE PATIENT NEEDED TO BE CONNECTED FOR VENTILATION. - AS A RESULT OF STRUGGLING TO CONNECT THE BREATHING MASK TO THE BREATHING CIRCUIT, SOME VENTILATOR ALARMS WERE ACTIVATED. - THE DEVICE LOG FILES WERE NOT PROVIDED TO HAMILTON. - THERE IS PATIENT INVOLVEMENT REPORTED (INFANT, 20 MONTHS OLD, 9KG). - THERE WAS NEED FOR MEDICAL INTERVENTION REPORTED. THE VENTILATOR DEVICE AND THE BREATHING CIRCUIT SET GOT REPLACED. - NEITHER HARM TO THE PATIENT, USER OR THIRD PARTY HAS BEEN REPORTED. THERE IS NO DELAY IN TREATMENT REPORTED AS SUCH BUT BASED ON THE INFORMATION WHAT HAS BEEN REPORTED, IT CAN BE CONCLUDED THAT THIS EVENT CAUSED A CERTAIN DEGREE OF UNCERTAINTY BETWEEN THE HOSPITAL STAFF. THE INVESTIGATION IS ONGOING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18594401 ↗
Other Set, Tubing And Support, Ventilator (W Harness) devices
- Breathing circuit set, coaxial 260128Hamilton Medical AG · Set, Tubing And Support, Ventilator (W Harness)2 recalls10 reports
- Percussionaire P5-TEEPercussionaire Corporation · Set, Tubing And Support, Ventilator (W Harness)2 recalls1 report
- F&P FlexiTrunk BC191-05Fisher & Paykel Healthcare Limited · Set, Tubing And Support, Ventilator (W Harness)76 reports
- 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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