MAUDE Adverse Event Report: VYAIRE MEDICAL AIRLIFE® FILTERED SMALL VOLUME NEBULIZER SYSTEM; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number	AIRLIFE® FILTERED SMALL VOLUME NEBULIZER SYSTEM
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Bronchospasm (2598)
Date of Event	05/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to vyaire medical that the patient experience a bronchospasm after using 124030eu airlife filtered nebulizer.
Additional Manufacturer Narrative
H3: 81 other - the customer did not send picture or the physical sample of the fg part number 124030eu for the investigation.We require either the physical sample and/or pictures to perform a further investigation and look for the possible cause of the reported defect.In addition, we were unable to review the device history record since the lot number was not provided for the investigation.Therefore, the defect reported by the customer was not confirmed.There are two patients involved in this incident.Please refer to (b)(4) for the 2nd patient.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.H3: device was not returned.

• Brand Name: AIRLIFE® FILTERED SMALL VOLUME NEBULIZER SYSTEM
• Common Device Name: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada vía de la producción; no. 85, parque undustrial; mexicali 21397 ; MX 21397
• Manufacturer Contact: erika bonilla ; 510 technology drive; irvine, CA 92618
• MDR Report Key: 17051811
• Report Number: 8030673-2023-00327
• Device Sequence Number: 6814498
• Product Code: CAF
• UDI-Device Identifier: 10190752144828
• UDI-Public: (01)10190752144828
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K874395
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/02/2023

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: Health Professional
• Device Model Number: AIRLIFE® FILTERED SMALL VOLUME NEBULIZER SYSTEM
• Device Catalogue Number: 124030EU
• 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: 05/04/2023
• Initial Report FDA Received Date: 06/02/2023
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown