MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-BC4022; HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER

Model Number	260186
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
High flow adult humidifier container had a water leak.This is the second container in the last couple weeks that the reporting emergency medical technician has encountered with a water leak.This is the second issue of the adult circuit being cracked that has been brought to my attention.In both cases, no impact to patient care.Both times, the circuit was in the bubble wrap, and the circuits should be sufficiently protected in their storage.First incident was reported to a supervisor.Also, concern was given to the supervisor about only having one adult humidifier container in the truck when we cannot switch the container.The first container was a minor leak, but the container used today soaked a bath blanket.Unfortunately, no pictures were taken, and the crew did not return the leaky circuit nor keep the packaging but discarded both.Action taken is that a second adult circuit will be added to the trucks to provide a backup.In follow up with the hamilton business manager was told that the adult hfnc circuits leaking is an issue that has been reported back to hamilton a handful of times in the last year.

• Brand Name: HAMILTON-BC4022
• Common Device Name: HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER
• Manufacturer (Section D): HAMILTON MEDICAL AG; 4655 aircenter circle; reno NV 89502
• MDR Report Key: 17001488
• Report Number: 17001488
• Device Sequence Number: 12302986
• Product Code: BZE
• UDI-Device Identifier: 07630002804189
• UDI-Public: 07630002804189
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/17/2023
• Report Date (Section F): 05/17/2023

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
• Operator of Device: Other
• Device Model Number: 260186
• Device Catalogue Number: 260186
• Device Lot Number: 1900079284
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Other
• Date Report to Manufacturer: 05/25/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/25/2023
• 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
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/17/2023