MAUDE Adverse Event Report: Hamilton Medical AG Hamilton-C1; Hamilton C1

Model Number	161001
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	07/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
While switching oxygen from tank to wall, alarm appeared "no oxygen " or "oxygen supply failed ".Duplicated the event in department and noticed that it took some time for the c1 to alarm that the vent had no oxygen.Once the o2 hose was plugged back in, the vent took some time to stop alarming "no oxygen." it seems to reset itself because the alarm disappears.Unsure if this is normal with c1's but it did result in both patients desatting.Another event happened when vent was turned on, immediately received an alarm for "oxygen supply failed ".I switched the quick connect and that seemed to fix the issue.I took that same quick connect to the department to trial it on another unit but did not receive the same issue.

• 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: 50182648
• Report Number: 3016723884-2026-00016
• Device Sequence Number: 15922851
• 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?: Yes
• Device Model Number: 161001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/20/2026
• 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