MAUDE Adverse Event Report: Hamilton Medical AG HAMILTON-C1

Model Number	1610010
Medical Device Problem Codes	No Audible Alarm (1019); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Hamilton medial ag received the following complaint description (summary): it was reported that, on (b)(6) 2026, a hamilton-c1 (product no.1610010, s/n (b)(6), sw 3.1.1) "did not audibly alarm while alarm condition existed on patient." patient involvement was reported.No patient, user, or third-party harm and no medical intervention were reported.
Additional Manufacturer Narrative
Hamilton medical ags reference: (b)(4); hamilton medical ags conclusion: it was reported that, on (b)(6) 2026, a hamilton-c1 (product no.1610010, s/n (b)(6), sw 3.1.1) "did not audibly alarm while alarm condition existed on patient." patient involvement was reported.No patient, user, or third-party harm and no medical intervention were reported.The reported event could not be reconstructed from the available logs.During subsequent testing, all tested alarm conditions generated audible and visual alarms.The alarm-system, loudspeaker, buzzer, alarm-monitor, and audio-pause tests were completed successfully.  the reported condition could not be reproduced, and no alarm-system malfunction was identified.No hardware replacement was required.The ventilator was returned to service after successful testing.  the reason why the audible alarm was reportedly not perceived could not be determined.Based on the investigation results, hamilton medical ag considers this case closed.

• Brand Name: HAMILTON-C1
• Common Device Name: HAMILTON-C1
• Manufacturer (Section D): Hamilton Medical AG; via crusch 8; bonaduz 7402 ; SZ 7402
• Manufacturer Contact: daniel elice ; via crusch 8; bonaduz 7402
• MDR Report Key: 50913717
• Report Number: 3001421318-2026-00608
• Device Sequence Number: 14952122
• Product Code: CBK
• UDI-Device Identifier: 07630002813426
• UDI-Public: (01)07630002813426(11)250903(240)1610010
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2026

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
• Operator of Device: Health Professional
• Device Model Number: 1610010
• Device Catalogue Number: 1610010
• 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: 09/10/2026
• Supplement Date Received by Manufacturer: 09/28/2026
• Initial Report FDA Received Date: 09/28/2026
• Supplement Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2025
• 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