MAUDE Adverse Event Report: Hamilton Medical AG HAMILTON-C6

Model Number	160021
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	09/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Hamilton medical ag received the following description: "suctioning was performed on the patient via the endotracheal tube.Suddenly, the patient's oxygen saturation dropped to 85%.The ventilator first issued a low minute volume warning, followed by a "patient circuit disconnected" alert.All connections were checked, but nothing was loose.The patient was not being ventilated.The flow sensor was replaced, but there was no change.A physician examined the airways using a fiberscope; mucus was found primarily within the endotracheal tube, but the airways themselves were clear.The ventilator was replaced, and the patient's condition stabilized.At the onset of the incident, the patient's etco2 waveform had flatlined, indicating that the patient was not actually being ventilated." no further patient consequences were reported.
Additional Manufacturer Narrative
Hamilton medical ag reference number: (b)(4).Investigation is ongoing.

• Brand Name: HAMILTON-C6
• Common Device Name: HAMILTON-C6
• Manufacturer (Section D): Hamilton Medical AG; via crusch 8; bonaduz 7402 ; SZ 7402
• Manufacturer (Section G): Hamilton Medical AG; via crusch 8; bonaduz 7402 ; SZ 7402
• Manufacturer Contact: alina ; via crusch 8; bonaduz 7402
• MDR Report Key: 50881059
• Report Number: 3001421318-2026-00595
• Device Sequence Number: 10683173
• Product Code: CBK
• UDI-Device Identifier: 07630002808590
• UDI-Public: (01)07630002808590(11)201023(240)160021
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K201658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 160021
• Device Catalogue Number: 160021
• 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: 09/18/2026
• Initial Report FDA Received Date: 09/24/2026
• Date Device Manufactured: 10/23/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown