MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-T1

Model Number	161009
Medical Device Problem Code	Image Orientation Incorrect (1305)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported the device's display was inverted when the unit power was turned on.There was no report of patient involvement; harm to patient, user or third party, nor a treatment in delay.No interruption of ventilation or medical intervention was reported.The display connector on control board missing locking tabs causing damage to display ribbon cable.The control board and display ribbon cable was replaced to correct the problem.After performing service software checks per manufacturer specifications the unit passed all functional tests and the unit was returned to service.No further problems have been reported, no additional investigation is deemed necessary at this time.This case is considered as closed.
Event or Problem Description
Hamilton medical ag received the following event description: display is inverted when unit power on - no patient involvement - no intervention necessary.

• Brand Name: HAMILTON-T1
• Common Device Name: HAMILTON-T1
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz 7402 ; SZ 7402
• Manufacturer Contact: ann franz ; via crusch 8; bonaduz 7402 ; SZ 7402
• MDR Report Key: 25212392
• Report Number: 3001421318-2026-00306
• Device Sequence Number: 10574419
• Product Code: CBK
• UDI-Device Identifier: 07630002806091
• UDI-Public: 07630002806091
• 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: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/19/2026

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
• Device Model Number: 161009
• Device Catalogue Number: 161009
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 05/19/2026
• Is the Device Labeled for Single Use? (Y/N): No
• 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