MAUDE Adverse Event Report: VYAIRE MEDICAL, INC. AIRLIFE; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number	002446
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
While preparing to stock a hospital unit, a respiratory therapist noticed that an unopened nebulizer package was missing a nebulizer cup and mouthpiece.

• Brand Name: AIRLIFE
• Common Device Name: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): VYAIRE MEDICAL, INC.; 510 technology dr; irvine CA 92618
• MDR Report Key: 14564147
• Report Number: 14564147
• Device Sequence Number: 14883802
• Product Code: CAF
• UDI-Device Identifier: 10190752114937
• UDI-Public: (01)10190752114937(17)260223(10)0004178665
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/03/2022
• Report Date (Section F): 05/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 002446
• Device Catalogue Number: 002446
• Device Lot Number: 0004178665
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/01/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/01/2022
• 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
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/27/2022