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	06/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag case number is: (b)(4).
Event or Problem Description
The following was reported to hamiton medical ag: intermittently fails the tightness check.Flow passes through the circuit & diphram cover, out the exhalation port of the cover.Failed service software tests: prox tests: proximal pressure & proximal flow.Occurred during a test.No patient involvement.
Additional Manufacturer Narrative
Hamilton medical ag case number is: (b)(4).Follow-up 1 - corrected information: **udi related data quality updates only** a udi-di was provided for this device brand and version (generally) in the initial report, yet hamilton medical ag (hmag) established that this particular device (serial number: (b)(6) was not labelled with a udi at the time of its manufacturing.Creation of udi was not a requirement at the time of manufacturing of this particular device (prior to 2015) and had not yet been implemented in production at hmag.Udi data has therefore been removed in this corrected follow-up report.A full udi (including udi-pi) will not be provided, this is in alignment with the information on the label on the device with the serial number (b)(6).
Event or Problem Description
The following was reported to hamiton medical ag: intermittently fails the tightness check.Flow passes through the circuit & diphram cover, out the exhalation port of the cover.Failed service software tests: prox tests: proximal pressure & proximal flow.Occurred during a test.No patient involvement.
Event or Problem Description
The following was reported to hamiton medical ag: intermittently fails the tightness check.Flow passes through the circuit & diphram cover, out the exhalation port of the cover.Failed service software tests: prox tests: proximal pressure & proximal flow.Occurred during a test.No patient involvement.
Additional Manufacturer Narrative
Hamilton medical ag case number is: (b)(4).Follow-up 1 - corrected information: **udi related data quality updates only** a udi-di was provided for this device brand and version (generally) in the initial report, yet hamilton medical ag (hmag) established that this particular device (serial number: (b)(6)) was not labelled with a udi at the time of its manufacturing.Creation of udi was not a requirement at the time of manufacturing of this particular device (prior to 2015) and had not yet been implemented in production at hmag.Udi data has therefore been removed in this corrected follow-up report.A full udi (including udi-pi) will not be provided, this is in alignment with the information on the label on the device with the serial number (b)(6).Updated fields: b4, d1, d4, g6, h2, h4, h11.Follow-up 2 - additional information: fields b4, g6, h2, h6 and h11 are updated.Tightness test failed during pre-operational check.No patient involved.Consequently, the event did not cause or contributed to a death or serious injury.The tightness test is performed during startup of the ventilator to verify the integrity of the breathing circuit, ensuring there are no leaks that could compromise ventilation.The test is designed to detect leaks in the ventilator circuit, including tubing, connections, and the patient interface.Both the tightness test and the compensatory mechanisms for minor leaks are designed to ensure the ventilator operates safely and effectively.A failed tightness test or minor leak detection during ventilation does not indicate a malfunction but rather triggers the ventilator's safety mechanisms to either alert the operator or adapt to the situation.In conclusion, a failed tightness test is not a malfunction and should not be viewed as an immediate or critical failure.There is no information that reasonably suggest that the device has malfunctioned and that the device or a similar device would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.Therefore, based on this information, the event is assessed as no longer reportable and the event 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: christof mueller ; via crusch 8; bonaduz, 7402 ; SZ 7402
• MDR Report Key: 19748568
• Report Number: 3001421318-2024-01713
• Device Sequence Number: 6491326
• Product Code: CBK
• UDI-Device Identifier: 07630002813549
• UDI-Public: 07630002813549
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/16/2025

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2024
• Supplement Date Received by Manufacturer: 07/01/2024; 07/01/2024
• Initial Report FDA Received Date: 07/16/2024
• Supplement Report FDA Received Date: 11/26/2024; 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2012
• 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