MAUDE Adverse Event Report: VYAIRE MEDICAL INSTRUMENT ASSY V62W AUTOBOX; SPIROMETER, DIAGNOSTIC

Model Number	INSTRUMENT ASSY V62W AUTOBOX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	11/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
The customer reported that a patient had a severe reaction with the mouthpiece that was used on the first dlco (diffusing capacity for carbon monoxide) during spirometry test.The patient was taken to the emergency room and was hospitalized for three days due to a severe reaction that caused him to be severely short of breath.

• Brand Name: INSTRUMENT ASSY V62W AUTOBOX
• Common Device Name: SPIROMETER, DIAGNOSTIC
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 10946654
• Report Number: 2021710-2020-12944
• Device Sequence Number: 14583152
• Product Code: BZG
• UDI-Device Identifier: 10846446021295
• UDI-Public: (01)10846446021295
• Combination Product (Y/N): N
• PMA/510(K) Number: K942211
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Type of Report: Initial
• Report Date (Section B): 11/09/2020

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: INSTRUMENT ASSY V62W AUTOBOX
• Device Catalogue Number: 773835-103
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 12/04/2020
• 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: Required Intervention