MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; COMPRESSOR,NEBULIZER,WITH CARRY BAG

Catalog Number	HCSFISHNEBH
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	04/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the customer the nebulizer is not dispensing the medication, and the user has missed their breathing treatment of "pulmicort".
Additional Manufacturer Narrative
According to the customer the nebulizer is not dispensing the medication, and the user has missed their breathing treatment of "pulmicort".Per the customer the user of the device is 9 months old and "is beginning to show signs of breathing issues".Per the customer, they have not had to go to the hospital or required medical treatment at this time, and they have no other way of delivering the required medication.The device has been requested for evaluation.No additional information is available at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Common Device Name: COMPRESSOR,NEBULIZER,WITH CARRY BAG
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 22018887
• Report Number: 1417592-2025-00226
• Device Sequence Number: 9446949
• Product Code: BTI
• UDI-Device Identifier: 10884389197455
• UDI-Public: 10884389197455
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/14/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: HCSFISHNEBH
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 9 MO
• Patient Sex: Unknown