MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-C3

Model Number	160005
Medical Device Problem Code	Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag ref nr: (b)(4).
Event or Problem Description
The following was reported to hamilton medical ag: "hamilton c3 sn (b)(6) 'turned off while in use".No health consequences or impact.
Additional Manufacturer Narrative
The reported issue of external power loss appears to be related to a power supply interruption, potentially due to a loose or improperly connected main plug.This is supported by the following observations: no ambient mode was recorded in the log file, indicating the device did not enter a low-power state, which would typically occur during a controlled power-down.No ventilation failure or other system errors were logged on he day of the event, ruling out internal system faults.During follow-up testing, the engineer noted that batteries were not initially recognized, but were detected after being re-seated, suggesting a possible connection issue either with the battery contacts or the power input.Several attempts were made to contact the service technician to obtain additional information about the case; however, no response was received.The case will be closed for now and may be reopened if further information becomes available.Further investigation was attempted; however, no additional information was provided by the hospital.The available information is insufficient to reach a conclusive outcome.No parts were available for further inspection.For hamilton medical, this complaint is considered closed.We will continue monitoring similar events.At this time, no root cause can be identified due to the lack of information.

• Brand Name: HAMILTON-C3
• Common Device Name: HAMILTON-C3
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz
• Manufacturer Contact: christof mueller ; via crusch 8; bonaduz
• MDR Report Key: 21941005
• Report Number: 3001421318-2025-00579
• Device Sequence Number: 8358651
• Product Code: CBK
• UDI-Device Identifier: 07630002801881
• UDI-Public: (01)07630002801881(11)190621(240)160005
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K181216
• 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,Followup
• Report Date (Section B): 03/18/2026

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
• Device Model Number: 160005
• Device Catalogue Number: 160005
• Was Device Available for Evaluation?: No
• 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: 04/14/2025
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/21/2019
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown