MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-G5

Model Number	159002
Medical Device Problem Code	Intermittent Communication Failure (4038)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag ref.Nr: (b)(4).Investigation ongoing.
Event or Problem Description
Hamilton medical ag received the following event description: the device showed tf 9950.No patient involvement.
Additional Manufacturer Narrative
Follow-up 1: investigation outcome.It was reported that the device alarmed with tf 9950 and approximately 7 minutes after ventilation start, the device delivered unexpectedly large volumes and abnormal parameter values; no patient involvement was reported.Logfile review shows repeated occurrences of tf 9950 (watchdog u-processor fault) along with additional watchdog and gcp-related technical faults (e.G., tf 9907, 9705, 9706), indicating instability in control/communication subsystems.The event timeline also includes multiple power interruptions (loss of mains power) and frequent disconnection, flow sensor, and volume-related alarms prior to the fault, suggesting unstable operating conditions or signal inconsistencies.High frequency and high minute volume alarms were recorded shortly before the reported behavior, aligning with the complaint of ¿large volumes.¿ the presence of watchdog faults points to a system reset or processor communication failure, which can lead to transient uncontrolled outputs.Investigation supports a probable root cause of hardware or communication failure within esm boards (ip/vu), consistent with watchdog-triggered resets.An ip esm and a vu esm were sent to customer to address the reported issue.The manufacturer has not received any further information upon request, nor have we received any further complaints about this device, so it is assumed that the problem has been solved after replacing the ip and the vu esm.Hamilton medical ag considers this case closed.

• Brand Name: HAMILTON-G5
• Common Device Name: HAMILTON-G5
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz
• Manufacturer (Section G): HAMILTON MEDICAL AG; via crusch 8; bonaduz
• Manufacturer Contact: alina liliana valean ; via crusch 8; bonaduz
• MDR Report Key: 24197908
• Report Number: 3001421318-2026-00041
• Device Sequence Number: 13170565
• Product Code: CBK
• UDI-Device Identifier: 07630002802208
• UDI-Public: (01)07630002802208(11)170412(240)159002
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2026

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: 159002
• Device Catalogue Number: 159002
• Was Device Available for Evaluation?: No
• 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: 01/26/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/12/2017
• 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