MAUDE Adverse Event Report: HAMILTON MEDICAL AG BREATHING CIRCUIT SET, COAXIAL

Model Number	260128
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag complaint number: (b)(4).
Event or Problem Description
The following was reported to hamilton medical ag: hamilton medical ag received the following incident description: "crack in breathing set, transverse to a rib.Hose was taken out of the packaging with the crack.Hose stored as per manufacturer's instructions.The crack was discovered during the test.During the pre-operational check.Delayed deployment as a second breathing set had to be organised (planned relocation)".No harm to the patient, user or third party has been reported.
Additional Manufacturer Narrative
Hamilton medical ag complaint number: cer (b)(4).A detailed investigation was performed by an expert from the technical service: the self-test is performed during the ventilator's startup process, prior to patient connection.This test ensures that the ventilator's components, including alarms, sensors, and circuits, are functioning correctly.It is a standard safety feature to ensure that the ventilator is functioning correctly before it's used on a patient.A failed self-test does not indicate a malfunction but rather was designed to prevent it.It serves as a security check to ensure all systems are functioning properly.If self-test is failed, it does not imply immediate danger, but rather alert an issue that needs to be addressed to prevent future problems.In conclusion, a failed self-test should not be viewed as a malfunction and an immediate or critical failure, but as part of the pre-emptive safety and maintenance measure.As soon as the underlying issue is addressed properly, the ventilator can be safely used on patients.Therefore, a failed self-test is not considered a reportable event.Cut in breathing set => analysis showed that this was not a material related issue but most likely an user issue when he open the box with a cutter.Notes: - if it is noted in the complaint that the device was immediately needed for a patient and the failed self test has led to a significant delay and/or necessary clinically relevant intervention, the case becomes reportable.A clinically significant delay for a life-saving device in intensive care must be considered a reportable event which was not the case here.
Event or Problem Description
The following was reported to hamilton medical ag: - hamilton medical ag received the following incident description: "crack in breathing set, transverse to a rib.Hose was taken out of the packaging with the crack.Hose stored as per manufacturer's instructions.The crack was discovered during the test.During the pre-operational check.Delayed deployment as a second breathing set had to be organised (planned relocation)".- no harm to the patient, user or third party has been reported.

• Brand Name: BREATHING CIRCUIT SET, COAXIAL
• Common Device Name: BREATHING CIRCUIT SET, COAXIAL
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz, 7402 ; SZ 7402
• Manufacturer (Section G): HAMILTON MEDICAL AG; via crush 8; bonaduz, 7402 ; SZ 7402
• Manufacturer Contact: albert beckers ; via crush 8; bonaduz, 7402 ; SZ 7402
• MDR Report Key: 20733301
• Report Number: 3001421318-2024-02743
• Device Sequence Number: 8922455
• Product Code: BZO
• UDI-Device Identifier: 07630002802963
• UDI-Public: (01)07630002802963(10)189137(11)231101(17)281024(240)260128
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: EXEMPT
• 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
• Report Date (Section B): 02/25/2025

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: 260128
• Device Catalogue Number: 260128
• Device Lot Number: 189137
• 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: 11/07/2024
• Supplement Date Received by Manufacturer: 11/07/2024
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 02/25/2025
• Date Device Manufactured: 11/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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