MAUDE Adverse Event Report: WESTMED LLC WESTMED LLC; MINI-HEART, HI-FLO CONTINUOUS NEBULIZER,PED.AERO MASK,7'

Model Number	100613A
Medical Device Problem Code	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The treatment to the patient was delayed.
Event or Problem Description
Not nebulizing when connected to flowmeters.
Additional Manufacturer Narrative
The treatment to the patient was delayed.In the absence of a sample or photos the defect could not be confirmed.However based on the customer information the most likely root cause was identified to be an occlusion within subassembly 0697.The ultimate risk of low identified during the risk analysis does not justify initiating a capa.Airlfie will continue to monitor product feedback and complaints through complaint trending analysis monthly for all products per our internal quality system procedures.
Event or Problem Description
Not nebulizing when connected to flowmeters.

• Brand Name: WESTMED LLC
• Common Device Name: MINI-HEART, HI-FLO CONTINUOUS NEBULIZER,PED.AERO MASK,7'
• Manufacturer (Section D): WESTMED LLC; 5580 s nogales highway; tuscon AZ 85706
• Manufacturer (Section G): WESTMED LLC; 5580 s nogales highway; tuscon AZ 85706
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 18727855
• Report Number: 2028807-2024-00004
• Device Sequence Number: 12320941
• Product Code: CAF
• UDI-Device Identifier: 00709078000256
• UDI-Public: 00709078000256
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2024

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
• Operator of Device: Health Professional
• Device Model Number: 100613A
• Device Catalogue Number: 100613A
• Device Lot Number: 444210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2024
• Supplement Date Received by Manufacturer: 01/18/2024
• Initial Report FDA Received Date: 02/16/2024
• Supplement Report FDA Received Date: 04/18/2024
• 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