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

Model Number AIRLIFE® FILTERED SMALL VOLUME NEBULIZER SYSTEM

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Bronchospasm (2598)

Event Date 05/04/2023

Event Type  Injury  

Event Description

It was reported to vyaire medical that the patient experience a bronchospasm after using 124030eu airlife filtered nebulizer.

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
• Type of Device: 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
• MDR Text Key: 316430358
• Report Number: 8030673-2023-00327
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 10190752144828
• UDI-Public: (01)10190752144828
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K874395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 05/04/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other