MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-G5; Ventilator, continuous, facility use

Model Number	159001
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	01/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Complaint reported to hmi clinical application specialist: during interhospital transport of a patient the user reported a "no oxygen" failure when connected to o2 tank.The patient began to desaturate so the user switched the o2 tank.Once in the room the user removed the ventilator and switched to another hamilton-g5.Reported ventilator settings were: "100% 02, peep +16, vt 430, rr 28, 5l flow trigger." (description of events provided by rt manager at facility, not present during the event.Direct report from user not available at this time.).

• Brand Name: HAMILTON-G5
• Common Device Name: Ventilator, continuous, facility use
• Manufacturer (Section D): HAMILTON MEDICAL AG; parc lndustrial vial 10; domat/ems, graubunden 7013 ; SZ 7013
• MDR Report Key: 25615934
• Report Number: 3016723884-2026-00006
• Device Sequence Number: 9011897
• Product Code: CBK
• UDI-Device Identifier: 07630002800013
• UDI-Public: 07630002800013
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/13/2026
• Report Date (Section F): 06/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 159001
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/13/2026
• Event Location: Hospital
• Date Report to Manufacturer: 06/24/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/24/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown
• Date Report Sent to FDA: 06/24/2026