MAUDE Adverse Event Report: VYAIRE MEDICAL MASTERSCREEN PFT BODY; CALCULATOR, PULMONARY FUNCTION DATA

Model Number	JAEGER
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer reported the device is not available for evaluation.Due to the device not being available for analysis, no further evaluation can be completed at this time.
Event or Problem Description
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.

• Brand Name: MASTERSCREEN PFT BODY
• Common Device Name: CALCULATOR, PULMONARY FUNCTION DATA
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• MDR Report Key: 8925567
• Report Number: 9615102-2019-00108
• Device Sequence Number: 16216010
• Product Code: BZC
• UDI-Device Identifier: 04250892900810
• UDI-Public: (01)04250892900810(11)170808
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K122699
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/10/2019

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: JAEGER
• Device Catalogue Number: 172520
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2019
• Initial Report FDA Received Date: 08/23/2019
• 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
• Patient Age: 56 YR