MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-C6

Model Number	160021
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag`s conclusion: investigation is ongoing.
Event or Problem Description
Hamilton medical ag received the following: (1) complaint description (quatation from the customer/reporter): "after startup device gives 231007 (o2 controller flow high) and 231008 (o2 valve leak) technical event.Can hear that hpo o2 is leaking somewhere.From service menu - sensor data - flow sensor qo2 is showing ~17l/min even when flow is set to 0." (2) health impact: no patient involved.
Additional Manufacturer Narrative
Corrected data: added missed 510k number: k201658.
Additional Manufacturer Narrative
Additional information: hamilton medical comes to the following conclusion: the event happened during startup of the ventilator, where the user observed technical events (te) 231007 (tagd_o2controllerflowhigh) and te 231008 (tagd_o2valveleak) without patient involvement.Additionally, the user reported an audible o2 leak and a failed self-test, with sensor data showing an unexpected qo2 flow of ~17 l/min despite the flow being set to zero.Logfile analysis showed that no ambient mode was triggered, and the events were isolated to the o2 mixer block, which showed deviation during calibration.The root cause was a defective control valve within the mixer assembly.The o2 mixer block was replaced resolving the issue.No patient was harmed, and the ventilator was restored to full function and returned to clinical use.Correction: updated imdrf coding in section h6.

• Brand Name: HAMILTON-C6
• Common Device Name: HAMILTON-C6
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch; 8; bonaduz
• Manufacturer Contact: daniel elice ; via crusch; 8; bonaduz
• MDR Report Key: 21341559
• Report Number: 3001421318-2025-00254
• Device Sequence Number: 20754398
• Product Code: CBK
• UDI-Device Identifier: 07630002800372
• UDI-Public: (01)07630002800372(11)240925(240)160001
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/19/2025

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: 160021
• Device Catalogue Number: 160021
• 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: 01/29/2025
• Supplement Date Received by Manufacturer: 01/29/2025; 08/19/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 02/10/2025; 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/25/2024
• 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