MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON MEDICAL AG; HAMILTON-T1

Model Number	HAMILTON-T1
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag case number is cer (b)(4).Investigation ongoing.
Event or Problem Description
The following was reported to hamilton medical ag: this event was reported to hamilton as ventilator device failed for tightness test and alarmed.The tightness test is standard part of the preoperational check and gets performed when the breathing circuit is replaced.The tightness test is also part of the service software what gets performed during maintenance.Based on the available information, for this reported incident the first applies, namely during preoperational check.The continuous alarm was observable both visually and through hearing.Te 241002 (tightness test release valve defect).The device log files were provided to hamilton.There is no patient involvement reported.There is no need for any medical intervention reported.Neither delay in treatment nor harm to the patient, user or third party has been reported.The investigation is still ongoing.
Additional Manufacturer Narrative
Hamilton medical ag case number is (b)(4).Investigation ongoing.Follow-up 1 - corrected information: udi related data quality updates only.Field d4 was updated with full udi information as requested.
Event or Problem Description
The following was reported to hamilton medical ag: this event was reported to hamilton as ventilator device failed for tightness test and alarmed.The tightness test is standard part of the preoperational check and gets performed when the breathing circuit is replaced.The tightness test is also part of the service software what gets performed during maintenance.Based on the available information, for this reported incident the first applies, namely during preoperational check.The continuous alarm was observable both visually and through hearing.Te 241002 (tightnesstestreleasevalvedefect).The device log files were provided to hamilton.There is no patient involvement reported.There is no need for any medical intervention reported.Neither delay in treatment nor harm to the patient, user or third party has been reported.The investigation is still ongoing.
Event or Problem Description
The following was reported to hamilton medical ag: this event was reported to hamilton as ventilator device failed for tightness test and alarmed.The tightness test is standard part of the preoperational check and gets performed when the breathing circuit is replaced.The tightness test is also part of the service software what gets performed during maintenance.Based on the available information, for this reported incident the first applies, namely during preoperational check.The continuous alarm was observable both visually and through hearing.Te 241002 (tightness test release valve defect).The device log files were provided to hamilton.There is no patient involvement reported.There is no need for any medical intervention reported.Neither delay in treatment nor harm to the patient, user or third party has been reported.The investigation is still ongoing.
Additional Manufacturer Narrative
Hamilton medical ag case number is cer (b)(4).Investigation ongoing.Additional information added in follow-up #2 cer (b)(4).Field b4, g6, h2, h3, h6 and h11 updated.Device alarms with (release valve defective) during pre operational check and tightness test failed.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.It ensures that there is no unintended gas leakage that could affect ventilation performance.The operator's manual specifies that the preoperational check, which includes the tightness test, must always be conducted prior to patient use.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 MEDICAL AG
• 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: albert beckers ; via crusch 8; bonaduz, 7402 ; SZ 7402
• MDR Report Key: 18344219
• Report Number: 3001421318-2023-04259
• Device Sequence Number: 6221894
• Product Code: CBK
• UDI-Device Identifier: 07630002813549
• UDI-Public: 07630002813549
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/25/2025

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: HAMILTON-T1
• Device Catalogue Number: 161009
• 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: Not provided
• Supplement Date Received by Manufacturer: 07/18/2024; 11/19/2023
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 08/06/2024; 05/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2020
• 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