MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-C6

Model Number	160021
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Hamilton medical ag received the following description: the device was ventilating the patient when it stopped suddenly.The device was showing multiple alarms related to the blower.The ventilator was replaced with another one.No harm to the patient was reported.
Additional Manufacturer Narrative
Hamilton medical ag reference number: (b)(4).The report contains also the investigation outcome.It was reported that the device was ventilating the patient when it suddenly stopped.The device then displayed multiple alarms related to the blower.The ventilator was subsequently exchanged.No patient harm was reported.Hamilton medical ag received and analyzed the device log files.The analysis confirmed that during ventilation, technical fault (tf) 431001 ¿ blower fault and tf 446029 ¿ ambient failure detected were triggered.Please see below an extract from the logfiles 117|2026-04-06 12:14:15|power |off ventilation software 118|2026-04-06 12:13:32|tf |446029 119|2026-04-06 12:13:32|tf |1746004 120|2026-04-06 12:13:32|tf |431001 121|2026-04-06 12:13:32|tf |1446029 122|2026-04-06 12:13:32|tf |1485001 the service technician replaced the blower module.Following the repair, the device successfully passed all service software checks and was returned to clinical use.Hamilton medical ag considers this case closed.

• 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 liliana valean ; via crusch 8; bonaduz 7402 ; SZ 7402
• MDR Report Key: 24870826
• Report Number: 3001421318-2026-00213
• Device Sequence Number: 9100514
• Product Code: CBK
• UDI-Device Identifier: 07630002808590
• UDI-Public: (01)07630002808590(11)211101(240)160021
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K201658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/14/2026

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: 160021
• Device Catalogue Number: 160021
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2021
• 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