MAUDE Adverse Event Report: VYAIRE MEDICAL CAP NEBULIZER 24 PACK; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number	CAP NEBULIZER 24 PACK
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	12/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sample device is not available for analysis.Therefore, no investigation can be performed.The device history record was reviewed by vyaire and there was no issues found.
Event or Problem Description
The customer reported that the patient's aerosol humidifier of cc10 cap nebulizer 24 pack has stopped producing mist even though the bottle had water in it and the flow was adequate.Patient stopped receiving humidity resulting in mucus plugging.Emergency tracheostomy change was done and the equipment was removed from the patient.Patient harm is not known at this time.

• Brand Name: CAP NEBULIZER 24 PACK
• Common Device Name: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• MDR Report Key: 9575549
• Report Number: 8030673-2020-00065
• Device Sequence Number: 11407794
• Product Code: CAF
• UDI-Device Identifier: 10885403199141
• UDI-Public: (01)10885403199141(10)0004070896
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K072119
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/17/2019

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: CAP NEBULIZER 24 PACK
• Device Catalogue Number: CC10
• Device Lot Number: 0004070896
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 01/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention