MAUDE Adverse Event Report: Hamilton Medical AG HAMILTON-T1

Model Number	161006
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2026
Type of Reportable Event	Malfunction

• Brand Name: HAMILTON-T1
• Common Device Name: HAMILTON-T1
• Manufacturer (Section D): Hamilton Medical AG; via crusch 8; bonaduz 7402 ; SZ 7402
• Manufacturer Contact: jan schaufelberger ; via crusch 8; bonaduz 7402 ; SZ 7402
• MDR Report Key: 50885235
• Report Number: 3001421318-2026-00598
• Device Sequence Number: 21512293
• Product Code: CBK
• UDI-Device Identifier: 07630002801850
• UDI-Public: (01)07630002801850(11)171115
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K181216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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: Health Professional
• Device Model Number: 161006
• Device Catalogue Number: 161006
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown