MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; COMPRESSOR,AEROMIST COLORS ,CHARCOAL

Catalog Number	HCS70004C
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, the nebulizer was "not misting" causing her to miss her "ipratropium bromide and albuterol sulfate" medications for "about 1 week".The customer reported she replaced the filter and "attachments" with no resolve.The customer reported when she took it to the medical device store they stated there was "no air compression".The customer reported she did not experience any respiratory symptoms as a result of the reported issue.The customer reported she bought a new device, is receiving her medication, and is doing "fine".The customer did not report any serious injury related to the reported event.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 again.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.
Event or Problem Description
According to the customer, the nebulizer was "not misting" causing her to miss her "ipratropium bromide and albuterol sulfate" medications for "about 1 week".

• Common Device Name: COMPRESSOR,AEROMIST COLORS ,CHARCOAL
• 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: 20832926
• Report Number: 1417592-2024-00993
• Device Sequence Number: 20992192
• Product Code: BTI
• UDI-Device Identifier: 00888277415044
• UDI-Public: 00888277415044
• 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): 12/03/2024

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: HCS70004C
• Device Lot Number: 6462106
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2024
• Initial Report FDA Received Date: 12/03/2024
• 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: 77 YR
• Patient Sex: Female
• Patient Weight: 107 KG