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

Model Number 001902A

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

Patient Problem No Code Available (3191)

Event Type  malfunction  

Event Description

When the pt inhaled on the incentive spirometer (to 500ml) she started coughing, and said something inhaled was in her throat.The pt coughed up two tiny pieces of thin clear - what appeared to be plastic.The pt required a bronchoscopy prior to the scheduled surgery to ensure the airway was not compromised.

• Brand Name: AIRLIFE VYAIRE INCENTIVE SPIROMETER
• Type of Device: SPIROMETER, THERAPEUTIC (INCENTIVE)
• Manufacturer (Section D): VYAIRE MEDICAL, INC. ; mettawa IL 60045
• MDR Report Key: 8961095
• MDR Text Key: 156765133
• Report Number: MW5089543
• Device Sequence Number: 1
• Product Code: BWF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 001902A
• Device Lot Number: CM18S27
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other