MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-MR1

Model Number	1610100
Medical Device Problem Code	Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag case number is (b)(4).The investigation is ongoing.
Event or Problem Description
The following was reported to hamilton medical ag: - hamilton medical ag received the following incident description: "the following technical failures occurred: tf444001 (battery totally discharged), tf446029(ambientfailuredetected), tf485001(ambientfailuredetected), tf785003 (pmchannelobservationfailed).- this occurrence was noticed at start-up during the booting process.No further details about when this happened were reported to hamilton medical ag.- 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).The investigation is ongoing.Follow-up 1 - additional information: the entry fields b4, g6, h2, h3, h6 and h11 have been updated.The issue occurred during start up of the device at non-clinical use.No patient involved.The event did not cause or contribute to a death or serious injury to a patient.The root cause of the event was the batteries totally discharged and is consequently a user error, attributed to the lack of necessary user actions.Although the root cause of the event was identified as use error, the incident remains reportable as a potential deterioration in patient's health condition (which did not happen) could not be fully excluded.
Event or Problem Description
The following was reported to hamilton medical ag: hamilton medical ag received the following incident description: "the following technical failures occurred: tf444001 (battery totally discharged), tf446029 (ambientfailuredetected), tf485001 (ambientfailuredetected), tf785003 (pmchannelobservationfailed).This occurrence was noticed at start-up during the booting process.No further details about when this happened were reported to hamilton medical ag.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: 20405167
• Report Number: 3001421318-2024-02432
• Device Sequence Number: 6261953
• Product Code: CBK
• UDI-Device Identifier: 07630002813556
• UDI-Public: (01)07630002813556(11)230425(240)1610100
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 09/12/2025

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: 1610100
• Device Catalogue Number: 1610100
• 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: 10/02/2024
• Supplement Date Received by Manufacturer: 10/02/2024
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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