MAUDE Adverse Event Report: VYAIRE MEDICAL INC. SPIROMETER VOLUME INCENTIVE 4000ML 12/CS; SPIROMETER, THERAPEUTIC (INCENTIVE)

Model Number	SPIROMETER VOLUME INCENTIVE 4000ML 12/CS
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2022
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
It was reported to vyaire medical that while a patient was using the incentive spirometer, the patient inhaled and felt something in the back of their throat.After the first breath, a small piece of plastic was coughed up.The customer confirmed that no further harm was noted.

• Brand Name: SPIROMETER VOLUME INCENTIVE 4000ML 12/CS
• Common Device Name: SPIROMETER, THERAPEUTIC (INCENTIVE)
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): CHINAMED PRODUCTS (CHINA) LTD.; xin tang industrial park; jiao tang town gaoyao district; 44526 100; CH 44526100
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 15332425
• Report Number: 3013421741-2022-00021
• Device Sequence Number: 6928210
• Product Code: BWF
• UDI-Device Identifier: 10190752131064
• UDI-Public: (01)10190752131064
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K791819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/07/2022

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: Lay User/Patient
• Device Model Number: SPIROMETER VOLUME INCENTIVE 4000ML 12/CS
• Device Catalogue Number: 001902A
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Race: White