MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-MR1

Model Number	161010
Medical Device Problem Code	Insufficient Cooling (1130)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag case number is cer (b)(4).
Event or Problem Description
The following was reported to hamilton medical ag: hamilton medical ag received the following incident description from a third-party service company named atlantic respiratory services inc: "the customer complaint of fan failure.Atlantic respiratory services inc.Troubleshot the issue and was able to duplicate issues, found fan intermittently stopped working and unit would throw fan failure alarm".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 cer (b)(4).Follow-up 1 - additional information: the entry fields b4, g6, h2, h3, h6 and h11 have been updated.It was reported that the device generated a "fan failure" alarm.No patient involvement.Consequently, the event did not cause or contribute to a death or serious injury to a patient.The customer did not provide event logs for analysis.A replacement fan was shipped to the customer.No confirmation was received regarding the resolution of the issue.Although the outcome could not be verified, it is assumed that the issue was resolved by replacing the fan, as no further complaints have been reported.
Event or Problem Description
The following was reported to hamilton medical ag: hamilton medical ag received the following incident description from a third-party service company named atlantic respiratory services inc: "the customer complaint of fan failure.Atlantic respiratory services inc.Troubleshot the issue and was able to duplicate issues, found fan intermittently stopped working and unit would throw fan failure alarm".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: 20564906
• Report Number: 3001421318-2024-02610
• Device Sequence Number: 12632939
• Product Code: CBK
• UDI-Device Identifier: 07630002800761
• UDI-Public: (01)07630002800761(11)210927(240)161010
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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: 505
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2024
• Supplement Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2021
• 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