Flow sensor 281637Recalls & reported problems
Hamilton Medical AG · Flow sensor for use with all HAMILTON ventilators, 188 cm, pediatric/adult, single-use · Class 1
- 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 07630002800860), received between Oct 27, 2023 and Oct 27, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
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.
MalfunctionOct 27, 2023Break; Break
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: A BREAK IN THE TRANSPARENT LINE OF THE FLOW SENSOR. THIS ABNORMITY WAS NOTICED IN THE PREPARATION STAGE, BEFORE USAGE. THERE IS NO PATIENT INVOLVEMENT REPORTED. THERE WAS NO NEED FOR ANY MEDICAL INTERVENTION REPORTED. NEITHER DELAY IN TREATMENT NOR HARM TO THE PATIENT, USER OR THIRD PARTY HAS BEEN REPORTED. THE INVESTIGATION IS STILL ONGOING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18017709 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.