MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-T1

Model Number	161006
Medical Device Problem Code	Unintended Electrical Shock (4018)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	01/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag ref.Nr: (b)(4).
Event or Problem Description
Hamilton medical ag received the following event description: quoted from the biomed."on (b)(6) 2026 at 04:08 or earlier rt was shocked while holding the t1 trolley handle.Device was described as running on battery.Rt received emergency medical care due to incident.Weather conditions at that time were negative single digit f.Vent was actively ventilating patient at that time.Bystanders witnesses loud zap.Measured leakage from co2 connection while on ac power is 6 ua.The description strongly suggests a large environmental electrostatic discharge event in my opinion, but i would like to ensure the device is safe regardless." no health consequences or impact.However, rt received emergency medical care due to incident (details not known).The case has not been reviewed yet by hamilton medical ag.Therefore, the failure description could not be confirmed yet.So far, no relation to the device has been established.
Additional Manufacturer Narrative
Investigation outcome: it was reported that on january 20, 2026, at approximately 04:08 (or earlier), a respiratory therapist (rt) experienced an electrical shock while holding the "handle" (confirmed to be the trolley handle).The device was reportedly actively ventilating a patient at the time and was described as running on battery power.Bystanders reportedly heard a loud ¿zap.¿ the rt reportedly received emergency medical care following the incident.The reporter noted ambient weather conditions were in the negative single-digit °f range at the time of the event.The device was replaced as a result of this complaint.Per review of device logs, out of tolerance voltage was noted on 24v_ps.Additional information provided by the biomed includes an electrical leakage measurement performed after the event: leakage measured from the co2 connection while on ac power was reported as 6 ¿a.Compared with the manual¿s values, 6 ¿a = 0.006 ma, which is far below 0.1 ma equipment leakage reference (setup for hamilton-t1 with communication board installed).Additional information was received that the rt was admitted to the emergency department and "still experiencing numbness in finger tip(s)." the customer was advised to perform the full iec 62353 electrical safety test set per the t1 service manual (section 7), documenting results as reference values.Additional information was received from the customer that they were intending to perform the testing, but no further information was provided after multiple attempts.This case is considered as closed.

• Brand Name: HAMILTON-T1
• Common Device Name: HAMILTON-T1
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz
• Manufacturer Contact: christof müller ; via crusch 8; bonaduz
• MDR Report Key: 24187264
• Report Number: 3001421318-2026-00036
• Device Sequence Number: 9600650
• Product Code: CBK
• UDI-Device Identifier: 07630002801850
• UDI-Public: (01)07630002801850(11)151104(240)161006
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2026

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: 161006
• Device Catalogue Number: 161006
• 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: 01/20/2026
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/04/2015
• 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