Jaeger 172520 (UDI 04250892900810)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04250892900810), received between Aug 23, 2019 and Oct 3, 2019 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 3, 2019Non Reproducible Results; Non Reproducible Results

  THE HEALTHCARE FACILITY REPORTED DURING PULMONARY FUNCTION TESTING, THE PATIENT ALLEGEDLY RECEIVED AN ELECTRICAL SHOCK. THE PATIENT IS CONNECTED TO THE EQUIPMENT THROUGH A PLASTIC MOUTHPIECE IN WHICH THERE IS A FILTER ATTACHED TO THE ELECTRONICS THAT IS CONTROLLED BY THE MASTER SCREEN SYSTEM. THE NURSE REPORTED THE INCIDENT OCCURRED DURING THE FLOW-VOLUME CURVE (FVC) AT THE END OF THE EXHALATION. JUST BEFORE THE END-OF-TEST (EOT) CRITERIA WAS REACHED, THE PATIENT FELL/JUMPED BACKWARDS, AND PASSED OUT FOR A FEW SECONDS. THE HEALTHCARE FACILITY CONFIRMED AT THE TIME OF THE INCIDENT ALL OF THE LIGHT/POWER IN THE ROOM DISAPPEARED. ADDITIONALLY, THE REPORTED INCIDENT OCCURRED AT THE SAME TIME CONSTRUCTION WORK BY THE ELECTRICIAN IN THE NEXT CONTROL CABINET TOOK PLACE. THE PATIENT HAS NO RECOLLECTION OF A STRANGE SOUND, AND NO RECOLLECTION IF THE PATIENT DID OR DID NOT TOUCH ANY PART OF THE HARDWARE. THE PATIENT HAS NO RECOLLECTION OF GETTING ZAPPED OR WHAT HAPPENED. THE PATIENT WAS TRANSFERRED TO THE TRAUMA CENTER FOR OBSERVATION. NO FURTHER INFORMATION ABOUT AN INJURY OR CONDITION OF THE PATIENT.

  Patient problems: Electric Shock

  MAUDE report 9151947 ↗
• InjuryAug 23, 2019Gas/Air Leak; Gas/Air Leak

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE LUNG TESTING SYSTEM DEVICE WAS LEAKING. THE EQUIPMENT WAS NOT WORKING PROPERLY AND THE FACILITY MAINTENANCE STAFF WAS NOTIFIED ABOUT THE ISSUE WHICH HAD IMMEDIATELY REPLACED THE DEFECTIVE ACCESSORIES. DUE TO THIS DEVICE MALFUNCTION, THE PATIENT'S TREATMENT TIME WAS DELAYED. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE INCIDENT; HOWEVER, THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8925567 ↗