BREATHING CIRCUITS
Report
- Report Number
- 3001421318-2026-00217
- Event Type
- Malfunction
- Date Received
- April 15, 2026
- Date of Event
- March 28, 2026
- Report Date
- April 15, 2026
- Manufacturer
- HAMILTON MEDICAL AG
- Product Code
- BZO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
HAMILTON MEDICAL REFERENCE NUMBER: (B)(4). INVESTIGATION IS ONGOING. HAMILTON COAXIAL BREATHING CIRCUIT FAMILY DEVICES IN THIS PRODUCT LINE ARE CLASSIFIED UNDER PRODUCT CODE BZO. ¿SET, TUBING AND SUPPORT, VENTILATOR (WITH HARNESS). PART NUMBER 260167 IS LISTED IN THE SAME PRODUCT FAMILY PER THE MANUFACTURER ¿S IFU, AND THEREFORE FALLS UNDER THE SAME FDA PRODUCT CLASSIFICATION.
IT WAS REPORTED TO HAMILTON MEDICAL AG THAT: "ALTHOUGH ALL TESTS HAD BEEN PASSED, THE PATIENT COULD NOT BE VENTILATED. AN ERROR MESSAGE APPEARED ON THE DEVICE (PEEP TOO HIGH, MINUTE VOLUME TOO LOW AND EXHALATION OBSTRUCTED). TO PREVENT HARM TO THE PATIENT, VENTILATION WAS CONTINUED USING A MANUAL RESUSCITATION BAG AND THE TUBING SYSTEM WAS REPLACED. VENTILATION THEN RESUMED. THE PROBLEM IS LIKELY TO LIE WITH THE EXPIRATORY VALVE. THE SAME PROBLEM HAS OCCURRED SEVERAL TIMES WITH THIS SYSTEM. DID THIS ACTUALLY RESULT IN SERIOUS CONSEQUENCES FOR THE PATIENT, USER OR THIRD PARTIES? NO POSSIBLE SERIOUS CONSEQUENCES AND EXPLAIN WHY IT WAS CLASSIFIED AS SERIOUS: OXYGEN DEPRIVATION DUE TO VENTILATION NOT BEING PERFORMED". IT WAS REPORTED THAT NO HEALTH CONSEQUENCES OR IMPACT TO THE PATIENT OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 103463 | BREATHING CIRCUITS | BREATHING CIRCUITS | BZO | HAMILTON MEDICAL AG | 260167 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |