MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-T1

Model Number	161005
Medical Device Problem Codes	Defective Component (2292); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event description according to the customer is as follows: delivered oxygen is 70-75% at a 90% setting.
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: delivered oxygen is 70-75% at a 90% setting.
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.Follow-up 1 - additional information: fields b4, g6, h2, h6 and h11 are updated.The unit alarmed with a low oxygen alarm during test.No patient involved.Consequently, the event did not cause or contribute to a death or serious injury.A low oxygen alarm itself is not a malfunction but a safety mechanism of the device that activates when monitored values deviate from the set range.There is no information that reasonably suggests the device has malfunctioned, nor that the device or a similar device would be likely to cause or contribute to a death or serious injury if the event were to recur.Therefore, based on this information, the event is assessed as no longer reportable, and the case can be closed with this follow-up report.

• 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: 20504313
• Report Number: 3001421318-2024-02527
• Device Sequence Number: 12817668
• Product Code: CBK
• UDI-Device Identifier: 07630002800754
• UDI-Public: (01)07630002800754(11)150528(240)161005
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 06/30/2025

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: 10/15/2024
• Supplement Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/14/2020
• 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