MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-T1

Model Number	161005
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag event reference number: cer (b)(4).The internal product investigation is still ongoing.As soon as the results are available, the manufacturer will submit an update of this report unsolicited.
Event or Problem Description
The event description according to the customer is as follows: customer complained of replacing expiratory valve assm and checkvalve more than normal every 3 months typical.
Additional Manufacturer Narrative
(b)(4).It was reported that the customer complained of replacing expiratory valve assembly and check valve more than normal every 3 months typical.No log files were provided.Expiratory valve assembly and check valve assembly were replaced, and the customer were trained on utilizing proper humidifier shutdown, filtering and cleaning practices and the device was released back into use.

• Brand Name: HAMILTON-T1
• Common Device Name: HAMILTON-T1
• 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: catalin nistor ; via crusch 8; bonaduz, 7402 ; SZ 7402
• MDR Report Key: 20210873
• Report Number: 3001421318-2024-02197
• Device Sequence Number: 7328359
• Product Code: CBK
• UDI-Device Identifier: 07630002800754
• UDI-Public: (01)07630002800754(11)150528(240)161005
• Combination Product (Y/N): N
• 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: 505
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2025

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: 161005
• Device Catalogue Number: 161005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/21/2022
• 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