MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON G5 CUSTOMIZED

Model Number	159002
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Personnel describe the hamilton g5 as not meeting iso (b)(6) standards and this causing confusion/extra training required for personnel.

• Brand Name: HAMILTON G5 CUSTOMIZED
• Common Device Name: HAMILTON G5
• Manufacturer (Section D): HAMILTON MEDICAL AG; parc lndustrial vial 10; domat/ems, ch 7013 ; SZ 7013
• MDR Report Key: 23650975
• Report Number: 3016723884-2025-00013
• Device Sequence Number: 21306323
• Product Code: CBK
• UDI-Device Identifier: 07630002800013
• UDI-Public: 07630002800013
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/07/2025
• Report Date (Section F): 11/25/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 159002
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/07/2025
• Event Location: Hospital
• Date Report to Manufacturer: 11/25/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/25/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 11/25/2025