MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-G5

Model Number	159001
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag reference number: (b)(4).Investigation outcome: user reported the error message ¿panel connection lost¿ occurring after normal device startup.The initially reported incident date was (b)(6) 2026.However, logfile analysis confirmed multiple ¿panel connection lost¿ alarms recorded on (b)(6) 2026.For this reason, the customer event date was aligned with the logfile records, while noting the discrepancy between the customer reported date and the system documented alarm occurrences.Technical evaluation identified the vu-esm (ventilation unit-embedded system module) as the root cause of the incident.After replacement of the esm, it was confirmed that the device operates according to its intended performance.There was no patient involvement.
Event or Problem Description
It was reported to hamilton medical ag that the user tried to turn on the device and the error message ¿panel connection lost¿ appeared.No patient was involved.

• Brand Name: HAMILTON-G5
• Common Device Name: HAMILTON-G5
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz 7402 ; SZ 7402
• Manufacturer Contact: roxana huiet ; via crusch 8; bonaduz 7402 ; SZ 7402
• MDR Report Key: 24559274
• Report Number: 3001421318-2026-00120
• Device Sequence Number: 21165001
• Product Code: CBK
• UDI-Device Identifier: 07630002800013
• UDI-Public: (01)07630002800013(11)201214(240)159001
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K193228
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/10/2026

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
• Operator of Device: Health Professional
• Device Model Number: 159001
• Device Catalogue Number: 159001
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 03/10/2026
• Date Device Manufactured: 12/14/2020
• 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