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

Model Number SPIROMETER VOLUME INCENTIVE 4000ML 12/CS

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/15/2022

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

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
• Type of Device: 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
• MDR Text Key: 299041061
• Report Number: 3013421741-2022-00021
• Device Sequence Number: 1
• Product Code: BWF
• UDI-Device Identifier: 10190752131064
• UDI-Public: (01)10190752131064
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K791819
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Race: White