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

Catalog Number	HCSFISHNEB
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the customer starting on 1/21, the nebulizer stopped working.
Additional Manufacturer Narrative
According to the customer starting on 1/21, the nebulizer stopped working.The nebulizer was received about a year and a half ago from a pediatrician in regards to her son's asthma.The customer stated, "over the week, my son was having really bad upper respiratory issues and we tried using the nebulizer several times".The customer stated it would turn on, but "there would be no power actually coming from it as far as to power up the medication for the nebulizer".The customer continued to stated that it "basically turns on, but it has no function completely so he ended up being hospitalized".There was no further information.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 2753
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 21398105
• Report Number: 1417592-2025-00080
• Device Sequence Number: 12737370
• Product Code: BTI
• UDI-Device Identifier: 10884389197455
• UDI-Public: 10884389197455
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 02/17/2025

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
• Device Catalogue Number: HCSFISHNEB
• Device Lot Number: 6462111
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 02/18/2025
• 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 YR
• Patient Sex: Unknown
• Patient Weight: 34 KG