MAUDE Adverse Event Report: VYAIRE MEDICAL, INC. AIRLIFE - VOLUMETRIC INCENTIVE SPIROMETER; SPIROMETER, THERAPEUTIC (INCENTIVE)

Model Number 001902A

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/15/2022

Event Type  malfunction  

Event Description

Patient was instructed on incentive spirometer.Patient felt something in back of throat after inhaling on is.Small piece of plastic coughed up after first breath.Fragment coughed up was retrieved and saved.

• Brand Name: AIRLIFE - VOLUMETRIC INCENTIVE SPIROMETER
• Type of Device: SPIROMETER, THERAPEUTIC (INCENTIVE)
• Manufacturer (Section D): VYAIRE MEDICAL, INC.; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 14944528
• MDR Text Key: 295415455
• Report Number: 14944528
• Device Sequence Number: 1
• Product Code: BWF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/05/2022,06/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 001902A
• Device Catalogue Number: 001902A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/05/2022
• Date Report to Manufacturer: 07/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21900 DA
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Race: White