MAUDE Adverse Event Report: HAMILTON MEDICAL AG INTELLICUFF STANDALONE

Model Number	951001
Medical Device Problem Code	Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ags reference: (b)(4).Hamilton medical ags conclusion: investigation ongoing.
Event or Problem Description
Hamilton medical ag received the following event description: intellicuff switched off while it was using on patient.Additional device needed.No health consequences or impact, were reported.The investigation to verify the allegation is still in progress.
Additional Manufacturer Narrative
Hamilton medical ags reference: (b)(4); hamilton medical ags conclusion: the complainant reported that the intellicuff switched off during use on a patient.No logfiles were available for analysis.Based on the investigation and available information, the most probable root cause was depletion or wear of the internal batteries.The complainant later confirmed: ¿the intellicuff wasn¿t connected to the hamilton-c6.The two internal batteries were empty.The customer replaced these two batteries.Back in use.¿ therefore, the reported device shutdown can be attributed to empty internal batteries, and normal device function was restored after battery replacement.No further device-related malfunction was identified.No further information received.Cased is considered closed.

• Brand Name: INTELLICUFF STANDALONE
• Common Device Name: INTELLICUFF
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz
• Manufacturer Contact: daniel elice ; via crusch 8; bonaduz
• MDR Report Key: 24330585
• Report Number: 3001421318-2026-00065
• Device Sequence Number: 4812624
• Product Code: BSK
• UDI-Device Identifier: 07630002800839
• UDI-Public: (01)07630002800839(11)210913(240)951001
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150893
• 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,Followup
• Report Date (Section B): 03/09/2026

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: 951001
• Device Catalogue Number: 951001
• 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: 02/11/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 03/09/2026
• Date Device Manufactured: 09/13/2021
• 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