MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-G5

Model Number	159001
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag reference number: (b)(4).The report contains also the device evaluation.The manufacturer has received the logfiles for analysis.According to the logfiles analysis exhalation obstruction alarm was recorded.2025-10-15 12:45:51 operating time: 8 hour(s) 37 minute(s) device 825.2025-10-15 12:45:51 operating time: 386 day(s) device 826.2025-10-15 12:45:51 power-on 2025-10-15 power 1.2025-10-11 17:36:45 humidifier off special 547.2025-10-11 17:36:45 power-off 2025-10-11 power 3.2025-10-11 17:32:21 standby on special 506.2025-10-11 17:32:21 nebulizer off special 501.2025-10-11 17:32:16 exhalation obstructed alarms 5015.2025-10-11 17:32:09 exhalation obstructed alarms 5015.The root cause was identified as a¿defective expiratory valve, which was subsequently replaced.Following the replacement, the device functioned as intended.
Event or Problem Description
Hamilton medical ag received the following event description: the device alarmed with "exhalation obstructed".No patient involved.

• Brand Name: HAMILTON-G5
• Common Device Name: HAMILTON-G5
• 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: 23741018
• Report Number: 3001421318-2025-00952
• Device Sequence Number: 18260181
• Product Code: CBK
• UDI-Device Identifier: 07630002800013
• UDI-Public: (01)07630002800013(11)220211(240)159001
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K193228
• 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
• Type of Report: Initial
• Report Date (Section B): 12/08/2025

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
• Operator of Device: Health Professional
• Device Model Number: 159001
• Device Catalogue Number: 159001
• 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: 11/24/2025
• Initial Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/11/2022
• 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