MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-MR1

Model Number	1610100
Medical Device Problem Codes	Battery Problem (2885); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag complaint number: (b)(4).Initial report.
Event or Problem Description
Both batteries are dislodging.
Additional Manufacturer Narrative
Hamilton medical ag complaint number: (b)(4).Follow-up 1: investigation outcome.It was reported that both batteries were dislodged from the device.No patient was connected at the time of the event.No device logs, photographs, or additional technical information were provided to the manufacturer for evaluation.Although it was mentioned that the pressure sensor assembly was replaced, the provided corrective action does not appear to address or explain the reported battery dislodgement.To date, no additional information has been received, and it has not been confirmed whether the issue was resolved.In general, a battery disconnection may occur due to physical damage to the battery compartment, which can result in loss of contact between the battery connector and the battery terminal.In such a case, a ¿loss of battery power¿ alarm would be generated based on the available information, the root cause of the reported battery dislodgement cannot be determined.

• Brand Name: HAMILTON-MR1
• Common Device Name: HAMILTON-MR1
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8, bonaduz; bonaduz
• Manufacturer (Section G): HAMILTON MEDIAL AG; via crusch 8; bonaduz
• Manufacturer Contact: albert beckers ; via crusch 8; bonaduz
• MDR Report Key: 21252145
• Report Number: 3001421318-2025-00173
• Device Sequence Number: 8038631
• Product Code: CBK
• UDI-Device Identifier: 07630002813556
• UDI-Public: (01)07630002813556(11)230425(240)1610100
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2026

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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/28/2025
• Supplement Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (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