MAUDE Adverse Event Report: VYAIRE MEDICAL JAEGER; CALCULATOR, PULMONARY FUNCTION DATA

Model Number	V-175420
Medical Device Problem Codes	Mechanical Problem (1384); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A vyaire support representative went on-site to evaluate the suspect device.The support representative performed the work order and was able installed the supplied demand valve.After testing the new demand valve with different increase volumes, all maneuvers were carried out properly by the new demand valve and the issue was resolved.The representative checked and tested the device through calibrations and test measurements and returned the device to service specifications.
Event or Problem Description
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.

• Brand Name: JAEGER
• Common Device Name: CALCULATOR, PULMONARY FUNCTION DATA
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• MDR Report Key: 8847823
• Report Number: 9615102-2019-00107
• Device Sequence Number: 2494664
• Product Code: BZC
• UDI-Device Identifier: 04250892900216
• UDI-Public: (01)04250892900216
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K122699
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: V-175420
• Device Catalogue Number: 175452-13
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2019
• Initial Report FDA Received Date: 07/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other