Jaeger V-175420Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04250892900216), received between Jul 31, 2019 and Jul 31, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Gas/Air Leak” (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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 31, 2019Mechanical Problem; Gas/Air Leak; Mechanical Problem; Gas/Air Leak

  THE CUSTOMER REPORTED DURING THE MASTERSCREEN BODY/DIFFUSION TESTING. THE DEMAND VALVE LEAKS. THE CUSTOMER REPORTED AFTER INSPIRATION THE PATIENT EXPERIENCED (NAUSEA) SICKNESS, GAG REFLEX, AND "OVERBLOWN" LUNG. THE CUSTOMER REPORTED THE SHUTTER DOES NOT OPEN ADEQUATELY AFTER EXPOSURE TIME AND THE PATIENTS EXHALES NEXT TO THE MOUTHPIECE. THE CUSTOMER REPORTED BEING UNABLE TO CARRY OUT MEASUREMENTS AND REPORTED THE MOST LIKELY CAUSE OF THE ISSUE IS THE DEMAND VALVE ASSEMBLY. THE CUSTOMER REPORTED THE PATIENT LEFT THE HOSPITAL WITHOUT ANY FURTHER ACTION (NO SURGERY, NO TREATMENT). THE CUSTOMER REPORTED THERE IS NO PATIENT INJURY ASSOCIATED WITH THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8847823 ↗