MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-T1

Model Number	1610060
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Hamilton medial ag received the following complaint description (summary): hamilton medical ag received a report concerning a recently purchased battery that showed an unexpected and rapid decrease in its state of health after approximately four months of use.Logfile data documented a decline in state of health from 59.5 percent to 22.2 percent and subsequently to 0 percent within a short period.After calibration, the battery reached only about 30 percent state of health, and a reduced capacity was confirmed.The customer stated that the behaviour was abnormal compared with other batteries of similar production.No health consequences, no impact on ventilation, and no medical intervention were reported.
Additional Manufacturer Narrative
Hamilton medical ags reference: (b)(4).Hamilton medical ags conclusion: based on the information available, the reported behavior of the battery is shown in the device log files.Battery 2 showed a rapid decrease in its state of health, reaching 0 percent during normal use, which triggered the message that replacement was required.The battery had been in service for approximately four months and the reduced capacity remained reproducible after recalibration.No patient was involved and no harm occurred.It was confirmed that after replacement of the battery the issue was solved.No further information received.

• Brand Name: HAMILTON-T1
• Common Device Name: HAMILTON-T1
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz 7402 ; SZ 7402
• Manufacturer Contact: daniel elice ; via crusch 8; bonaduz 7402 ; SZ 7402
• MDR Report Key: 24602850
• Report Number: 3001421318-2026-00131
• Device Sequence Number: 8569108
• Product Code: CBK
• UDI-Device Identifier: 07630002813532
• UDI-Public: (01)07630002813532(11)211119(240)1610060
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K181216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/16/2026

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
• Device Model Number: 1610060
• Device Catalogue Number: 1610060
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/19/2021
• 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