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

Model Number INSTRUMENT ASSY V62W AUTOBOX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Dyspnea (1816)

Event Date 11/09/2020

Event Type  Injury  

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 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
• Type of Device: SPIROMETER, DIAGNOSTIC
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: peter sparacio ; 26125 n. riverwoods blvd.; mettawa, IL 60045 ; 8333273284
• MDR Report Key: 10946654
• MDR Text Key: 219547816
• Report Number: 2021710-2020-12944
• Device Sequence Number: 1
• Product Code: BZG
• UDI-Device Identifier: 10846446021295
• UDI-Public: (01)10846446021295
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K942211
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: INSTRUMENT ASSY V62W AUTOBOX
• Device Catalogue Number: 773835-103
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention