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

Model Number 100613A

Device Problem Incomplete or Inadequate Connection (4037)

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

Event Date 01/13/2024

Event Type  malfunction  

Manufacturer Narrative

The treatment to the patient was delayed.

Event Description

Not nebulizing when connected to flowmeters.

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 Description

Not nebulizing when connected to flowmeters.

• Brand Name: WESTMED LLC
• Type of Device: 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
• MDR Text Key: 335757068
• Report Number: 2028807-2024-00004
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 00709078000256
• UDI-Public: 00709078000256
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 01/18/2024
• Initial Date FDA Received: 02/16/2024
• Supplement Dates Manufacturer Received: 01/18/2024
• Supplement Dates FDA Received: 04/18/2024
• 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