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	Cough (4457)
Date of Event	02/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the customer on 02/14/24 they "poured one vial of albuterol and the nebulizer was on for about 3 minutes when it stopped working, it started making a loud clunk noise and it stopped misting".
Additional Manufacturer Narrative
According to the customer on 02/14/24 they "poured one vial of albuterol and the nebulizer was on for about 3 minutes when it stopped working, it started making a loud clunk noise and it stopped misting".Per the customer they had to use their "space inhaler" as their daughter "has asthma and was constantly coughing all day".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: 18888653
• Report Number: 1417592-2024-00377
• Device Sequence Number: 7540187
• Product Code: BTI
• UDI-Device Identifier: 10884389197455
• UDI-Public: 10884389197455
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 03/12/2024

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: HCSFISHNEB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2024
• Initial Report FDA Received Date: 03/12/2024
• 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 Sex: Unknown