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

Model Number 002446

Device Problems Component Missing (2306); Packaging Problem (3007)

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

Event Date 05/03/2022

Event Type  malfunction  

Event 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
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): VYAIRE MEDICAL, INC.; 510 technology dr; irvine CA 92618
• MDR Report Key: 14564147
• MDR Text Key: 293104618
• Report Number: 14564147
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 10190752114937
• UDI-Public: (01)10190752114937(17)260223(10)0004178665
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/27/2022,05/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2022
• 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
• Date Report Sent to FDA: 05/27/2022
• Event Location: Hospital
• Date Report to Manufacturer: 06/01/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1