MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-MR1

Model Number	161010
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag complaint number: (b)(4).Hamilton medical ag complaint number: (b)(4).Follow-up 1 - device manufacturing date added.
Event or Problem Description
The following was reported to hamilton medical ag: - hamilton medical ag received the following incident description: "tightness check failed.Obstruction valve close pressure too low: 40.5 mbar (min: 43.0 mbar) visual inspection of obstr.Valve appears to be out of place".- it's not reported to hamilton medical ag when exactly the tightness test failed.The tightness test is standard part of the pre-operational 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.Since this was not reported we must assume that it happened during the pre-operational check what makes this event reportable.· 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.
Additional Manufacturer Narrative
Hamilton medical ag complaint number: (b)(4).Initial report:.
Event or Problem Description
The following was reported to hamilton medical ag: - hamilton medical ag received the following incident description: "tightness check failed.Obstruction valve close pressure too low: 40.5 mbar (min: 43.0 mbar) visual inspection of obstr.Valve appears to be out of place".- it's not reported to hamilton medical ag when exactly the tightness test failed.The tightness test is standard part of the pre-operational 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.Since this was not reported we must assume that it happened during the pre-operational check what makes this event reportable.· 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.
Additional Manufacturer Narrative
Hamilton medical ag complaint number: (b)(4).Initial report: ----------------------------------------------------------------------- hamilton medical ag complaint number: (b)(4).Follow-up 1 - device manufacturing date added   updated fields: h4 ----------------------------------------------------------------------- follow-up 2 - additional information:.It was reported that the tightness test on the ventilator did not pass during non-clinical use.No patient involved.The event did not cause or contributed to a death or serious injury to a patient.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.To address the issue, a check valve assembly was shipped to the customer.No feedback was received confirming whether the replacement resolved the issue.Although the outcome could not be verified, it is assumed that the issue was resolved by replacing the check valve assembly, as no further issues have been reported.-----------------------------------------------------------------------.
Event or Problem Description
The following was reported to hamilton medical ag: - hamilton medical ag received the following incident description: "tightness check failed.Obstruction valve close pressure too low: 40.5 mbar (min: 43.0 mbar) visual inspection of obstr.Valve appears to be out of place".- it's not reported to hamilton medical ag when exactly the tightness test failed.The tightness test is standard part of the pre-operational 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.Since this was not reported we must assume that it happened during the pre-operational check what makes this event reportable.· 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.

• Brand Name: HAMILTON-MR1
• Common Device Name: HAMILTON-MR1
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz, 7402 ; SZ 7402
• Manufacturer (Section G): HAMILTON MEDIAL AG; via crusch 8; bonaduz, 7402 ; SZ 7402
• Manufacturer Contact: albert beckers ; via crusch 8; bonaduz, 7402 ; SZ 7402
• MDR Report Key: 20680694
• Report Number: 3001421318-2024-02710
• Device Sequence Number: 12559632
• Product Code: CBK
• UDI-Device Identifier: 07630002800761
• UDI-Public: (01)07630002800761(11)210714(240)161010
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K153046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/16/2025

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: 161010
• Device Catalogue Number: 161010
• Device Lot Number: NOT APPLICABLE
• 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: 11/08/2024
• Supplement Date Received by Manufacturer: 11/08/2024; 11/08/2024
• Initial Report FDA Received Date: 11/14/2024
• Supplement Report FDA Received Date: 11/14/2024; 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/14/2021
• 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