MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-MR1

Model Number	1610100
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag case number is (b)(4).Investigation ongoing.
Event or Problem Description
The following was reported to hamilton medical ag: hamilton medical ag received the following incident description: "the ventilator device failed for the tightness test (leakage)".This occurrence was noticed during the pre-operational check.There is no prior indication that something was technically wrong with the ventilator device.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 ongoing.
Additional Manufacturer Narrative
Hamilton medical ag case number is (b)(4).Hamilton medical ag complaint number: (b)(4).Follow-up 1 - corrected information: udi related data quality updates only.Field d4 was updated with full udi information.Updated fields: b4, d1, d4, g6, h2, h4, h11.
Event or Problem Description
The following was reported to hamilton medical ag: hamilton medical ag received the following incident description: "the ventilator device failed for the tightness test (leakage)".This occurrence was noticed during the pre-operational check.There is no prior indication that something was technically wrong with the ventilator device.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 ongoing.

• 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: 19688326
• Report Number: 3001421318-2024-01625
• Device Sequence Number: 7155866
• Product Code: CBK
• UDI-Device Identifier: 07630002813556
• UDI-Public: (01)07630002813556(11)230620(240)1610100
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• 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: User Facility,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2024

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: 1610100
• Device Catalogue Number: 1610100
• 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: 06/20/2024
• Supplement Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 07/08/2024
• Supplement Report FDA Received Date: 11/11/2024
• Date Device Manufactured: 06/20/2023
• 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