MAUDE Adverse Event Report: Hamilton Medical AG HAMILTON-C1

Model Number	161001
Medical Device Problem Code	Circuit Failure (1089)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Hamilton medical ag received the following event description (summary): it was reported that, during an inspection on 21 august 2026, the self-test of a hamilton-c1 ventilator, s/n (b)(6) failed and technical faults (tf) 431002 and 444004 were displayed.No patient, user, or third party was involved.No harm or medical intervention was reported.
Additional Manufacturer Narrative
Hamilton medical ags reference: (b)(4); hamilton medical ags conclusion:   it was reported that a hamilton-c1 (pn 161001, s/n (b)(6)) failed the self-test and displayed technical fault (tf) 431002 (blowerdisconnected) and tf 444004 (voltageoutoftolerance).No patient involvement, harm, or medical intervention was reported.  investigation showed repeated occurrences of tf 431002 and tf 444004.The reported condition was attributed to a control-board-related electronic malfunction and was no longer observed after replacement of the control board.  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 ; SZ 7402
• MDR Report Key: 50945757
• Report Number: 3001421318-2026-00614
• Device Sequence Number: 10429123
• Product Code: CBK
• UDI-Device Identifier: 07630002800747
• UDI-Public: (01)07630002800747(11)210505(240)161001
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K181216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: 161001
• Device Catalogue Number: 161001
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2021
• 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