MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-MR1

Model Number	161010
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to hamilton medical ag that: ¿immediately after starting ventilation, mr1 displays the error messages ¿expiratory stenosis¿ and ¿peep too high.¿ a patient was connected and device was exchanged.No harm to the patient was reported.
Additional Manufacturer Narrative
Hamilton medical reference # (b)(4).Investigation outcome: according to the log files provided, the hamilton-mr1 ventilator displayed error messages: high peep and exhalation obstructed.The alarms appeared and cleared again within seconds, which indicates an intermittent restriction of expiratory flow.A patient was connected to the ventilator at the time of the incident, however the incident occurred immediately after the start of ventilation.Device was exchanged and no harm to the patient was reported.The video analysis confirmed a mechanical issue; the expiratory valve membrane does not lift properly and sticks to the valve cover.After the expiratory valve cover was changed, the device worked as intended.The case is considered as closed.

• Brand Name: HAMILTON-MR1
• Common Device Name: HAMILTON-MR1
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz 7402 ; SZ 7402
• Manufacturer (Section G): HAMILTON MEDICAL AG; via crusch 8; bonaduz 7402 ; SZ 7402
• Manufacturer Contact: roxana huiet ; via crusch 8; bonaduz 7402 ; SZ 7402
• MDR Report Key: 24415040
• Report Number: 3001421318-2026-00079
• Device Sequence Number: 20302998
• Product Code: CBK
• UDI-Device Identifier: 07630002800761
• UDI-Public: (01)07630002800761(11)180615(240)161010
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K153046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/23/2026

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: 161010
• Device Catalogue Number: 161010
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 02/23/2026
• Date Device Manufactured: 06/15/2018
• 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