MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-T1

Model Number	161005
Medical Device Problem Codes	Gas/Air Leak (2946); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag event reference number: (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: loud noises from ventilator.Leaking at respiratory valve.The device does not pass tightness test.
Additional Manufacturer Narrative
Follow-up 1 (final) - additional information: the entry fields b4, g6, h2, h3, h6 and h11 have been updated.The (b)(4) with the detailed complaint and failure description "loud noises from ventilator.Leaking at respiratory valve.Will not pass tightness tests" is a duplicate of (b)(4) with the mdr reference 3001421318-2024-02520.The reported event was therefore erroneously reported and can be closed.

• 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: 20504327
• Report Number: 3001421318-2024-02541
• Device Sequence Number: 18216598
• Product Code: CBK
• UDI-Device Identifier: 07630002800754
• UDI-Public: (01)07630002800754(11)131115(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): 11/06/2025

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: 10/18/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2013
• 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