Jaeger V-178500Recalls & reported problems
Jaeger Medical GmbH · Vyntus BODY · Class 2
- 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 04250892908304), received between Jan 8, 2026 and Jan 8, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Inaccurate Flow Rate” (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
- Inaccurate Flow Rate1
Patient problems
- Cough1
- Loss of consciousness1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 8, 2026Inaccurate Flow Rate
IT WAS REPORTED THAT DURING RECENT HISTAMINE PROVOCATION TESTING USING THE VYNTUS BODY APS SYSTEM, TWO PATIENTS EXPERIENCED DISCOMFORT DURING BRONCHIAL PROVOCATION TESTING WITH HISTAMINE. THE HISTAMINE CONCENTRATION USED WAS 16 MG/ML AND THE PROVOCATION PROTOCOL CONSISTED OF FOUR STEPS OF 0.015, 0.045, 0.18 AND 0.72. ONE PATIENT EXPERIENCED HOT FLUSHES AND DIZZINESS AND DEVELOPED BRONCHOCONSTRICTION WITH A SIGNIFICANT REDUCTION IN FEV, RESULTING IN A POSITIVE BRONCHIAL CHALLENGE RESPONSE. ANOTHER PATIENT DID NOT SHOW BRONCHOCONSTRICTION BUT FAINTED IN THE TEST BOOTH FOR A FEW SECONDS. NO FURTHER SYMPTOMS BEYOND DISCOMFORT, DIZZINESS AND FAINTING WERE REPORTED. IN ADDITION, CONCERNS WERE RAISED REGARDING THE NEBULIZER OUTPUT DURING USE OF THE APS SYSTEM. MEASUREMENTS PERFORMED ON SITE BY THE CUSTOMER USING SALINE SOLUTION AND A PRECISION SCALE INDICATED HIGHER NEBULIZER OUTPUT VALUES THAN EXPECTED BASED ON AVAILABLE TECHNICAL INFORMATION. THIS LED TO UNCERTAINTY REGARDING THE AMOUNT OF SUBSTANCE ADMINISTERED TO PATIENTS DURING BRONCHIAL PROVOCATION TESTING. FURTHERMORE, CONCERNS WERE EXPRESSED ABOUT THE RELIABILITY OF NEBULIZER PERFORMANCE WHEN DIFFERENT FILLING VOLUMES ARE USED. IT
Patient problems: Cough; Loss of consciousness
MAUDE report 24001206 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.