MAUDE Adverse Event Report: VYAIRE MEDICAL VMAX; CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION

Model Number	VMAX ENCORE 22D
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Several attempts have been made to retrieve the sample from the customer.At this time, vyaire has not received the suspected mouth piece for evaluation.Any additional information received from the customer will be included in a follow-up report.
Event or Problem Description
While using the vmax for pulmonary function testing, the patient's lips were sticking to the mouthpiece and causing their lips to bleed.

• Brand Name: VMAX
• Common Device Name: CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• MDR Report Key: 8713841
• Report Number: 2021710-2019-10389
• Device Sequence Number: 1888789
• Product Code: BTY
• UDI-Device Identifier: 10846446021417
• UDI-Public: (01)10846446021417(11)20060601
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K942211
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/19/2018

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: VMAX ENCORE 22D
• Device Catalogue Number: 777405-101
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2018
• Initial Report FDA Received Date: 06/19/2019
• 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