MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-C1

Model Number	161001
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Hamilton medical ag received the following event description: the report from hospital say: when the oxygen concentration is set above 80% during use, the oxygen concentration detection error is large, and the machine will alarm for low oxygen concentration and emit a loud noise - no health consequences or impact - the standby machine was immediately replaced.Additional information received on 1th may 2026: the report from hamilton medical technologies in china was received which provided new information about the case.The following was described: "when the oxygen concentration was set above 80% during use, there was a large error in oxygen concentration detection, and the machine issued a low oxygen concentration alarm and a roaring sound".The standby machine was immediately replaced and the medical equipment department was notified for repair.The medical equipment department contacted the manufacturer's engineer, and the device returned to normal after software reinstallation.No injury was caused as the problem was detected and the standby machine was replaced immediately during use.The failure may be caused by a malfunction at the oxygen inhalation valve, resulting in the mixed oxygen concentration failing to reach the set value; the roaring sound may be due to blockage at the oxygen inhalation valve.There is information that reasonably suggest that the device has malfunctioned and that the device or a similar device would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.Therefore, reportable.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: HAMILTON-C1
• Common Device Name: HAMILTON-C1
• 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: 25133950
• Report Number: 3001421318-2026-00273
• Device Sequence Number: 21202283
• Product Code: CBK
• UDI-Device Identifier: 07630002800747
• UDI-Public: (01)07630002800747(11)210416(240)161001
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 05/11/2026

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: 161001
• Device Catalogue Number: 161001
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 05/11/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown