MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; COMPRESSOR,NEBULIZER, CHARACTER, PUPPY

Catalog Number	HCSPUPPY
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
According to the customer on 01/04/2026, the "machine turns on but is no longer misting.".
Additional Manufacturer Narrative
According to the customer on 01/04/2026, the "machine turns on but is no longer misting." upon further investigation, the customer noted that the patient was unable to receive treatment and "had to get creative and buy other things to use in the meantime that were not helpful".The customer confirmed that there was no serious injury or medical treatment required and that her daughter was doing "just fine." 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.

• Brand Name: MEDLINE
• Common Device Name: COMPRESSOR,NEBULIZER, CHARACTER, PUPPY
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: alexa huskisson ; three lakes drive; northfield, IL 60093
• MDR Report Key: 24280798
• Report Number: 1417592-2026-00093
• Device Sequence Number: 21282864
• Product Code: BTI
• UDI-Device Identifier: 00888277678166
• UDI-Public: 00888277678166
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 02/06/2026

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 Catalogue Number: HCSPUPPY
• Device Lot Number: 6462210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 12 MO
• Patient Sex: Female
• Patient Weight: 10 KG