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

Catalog Number	HCSPUPPYH
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Codes	Bronchitis (1752); Dyspnea (1816); Cough (4457)
Date of Event	11/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, "a few weeks ago" the nebulizer started turning on but not dispensing the "albuterol" medication to her son.The customer reported her son takes albuterol for his "asthma" but, since the nebulizer stopped working, he has developed "shortness of breath, coughing, and bronchitis".The customer reported after the nebulizer stopped working, she visited his physician and was given an "albuterol" inhaler, however her son is unable to follow the directions in order to appropriately take the inhaler due to his age.The customer reported she went to the emergency room on (b)(6) 2024 due to shortness of breath and coughing, and her son was given a "steroid".The customer reported the emergency room also performed an "xray" which showed "something on his lung".The customer reported since the emergency room visit, his shortness of breath and coughing has gotten "a little better".No additional information is available at this time.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the customer, "a few weeks ago" the nebulizer started turning on but not dispensing the "albuterol" medication to her son.
Additional Manufacturer Narrative
Update to h6: investigation findings.Update to h6: investigation conclusions.

• Common Device Name: COMPRESSOR,NEBULIZER, CHARACTER, PUP
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 20892956
• Report Number: 1417592-2024-01013
• Device Sequence Number: 21093276
• Product Code: BTI
• UDI-Device Identifier: 00888277678166
• UDI-Public: 00888277678166
• 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,Followup
• Report Date (Section B): 12/24/2024

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: Health Professional
• Device Catalogue Number: HCSPUPPYH
• Device Lot Number: 6462212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2024
• Supplement Date Received by Manufacturer: 12/03/2024
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 12/24/2024
• 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 Age: 24 MO
• Patient Sex: Male
• Patient Weight: 15 KG