MAUDE Adverse Event Report: Hamilton Medical AG Hamilton-C1

Model Number	1610010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	07/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Rt was called to bedside due to nursing stating that ventilator was spontaneously shutting off.Rt came to bedside and nursing stated it happened while suctioning.Rt suctioned patient and all flow from the ventilator stopped completely and patient o2 saturations dropped to low 80's and required support from ambu bag to improve saturations.Rt replaced flow sensor and exhalation valve and still the machine shut off all flow after suctioning despite the patient spontaneously breathing.

• Brand Name: Hamilton-C1
• Common Device Name: Hamilton-C1
• Manufacturer (Section D): Hamilton Medical AG; parc lndustrial vial 10; domat/ems, graubunden 7013 ; SZ 7013
• MDR Report Key: 50182653
• Report Number: 3016723884-2026-00014
• Device Sequence Number: 15922853
• Product Code: CBK
• UDI-Device Identifier: 07630002813426
• UDI-Public: 07630002813426
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Type of Report: Initial
• Report Date (Section B): 08/07/2026
• Report Date (Section F): 08/07/2026

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
• Device Model Number: 1610010
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/07/2026
• Event Location: Hospital
• Date Report to Manufacturer: 08/07/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/07/2026
• 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: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 08/07/2026