MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-T1

Model Number	1610060
Medical Device Problem Code	Misconnection (1399)
Health Effect - Clinical Codes	Hypoventilation (1916); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The following was reported to hamilton medical ag: "patient was being ventilated in emergency department (ed) on a t1.During this the 'flip flow sensor' alarm was intermittently activating.Incident occurred on wed.(b)(6).Hospital staff reports tidal volumes dropped and patient monitored etco2 increased.Patient was removed from ventilator and manually bagged.(this case is reported under mfr nr: 3001421318-2025-00809, hamilton medical ref nr: (b)(4) patient put on a second t1 ventilator with a new circuit and flow sensor."flip flow sensor" alarm occurred again on the second ventilator on arrival to icu in transfer and patient required to be manually bagged again.(this is addressed in this case) both vents had passed preop test before use including the flow sensor test as per user manual.No health consequences or impact.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
Hamilton medical ag ref nr: (b)(4).
Additional Manufacturer Narrative
Investigation outcome: on troubleshooting by local service engineers, it was identified that the flow sensor tubes were connected inverted to the ventilators.It was also noticed that the device did pass flow sensor calibration during pre-opp check and the issue remains undetected, until the ventilation is started.This is when the device alarms for 'flip the flow sensor' with medium priority.The waveforms are also displayed inverted (negative flow) in this configuration.Once the flow sensor tubes are reversed the device stops alarming.The reported problem is the expected behaviour of the device.The issue was raised earlier by the same partner, and the detailed explanation was sent by the product manager in response.The sequence of calibration with correctly attached flow sensor tubes is as follows: disconnect the patient, flip flow sensor (use adapter), calibration in progress, flip flow sensor, calibration in progress.Sequence with incorrectly attached flow sensor tubes is as follows: disconnect the patient, calibration in progress, flip flow sensor, calibration in progress.At the end of the sequence of calibration with correctly attached flow sensor tubes, the position of all attachments in breathing circuit becomes final and no more flipping of flow sensor is needed before connecting it to the patient interface.However, during the incorrect sequence, the flow sensor is only flipped once and therefore would make it (nearly) impossible to attach it to a patient interface after completing the flow calibration until the flow sensor is flipped again.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 mueller ; via crusch 8; bonaduz
• MDR Report Key: 23070497
• Report Number: 3001421318-2025-00807
• Device Sequence Number: 9738293
• Product Code: CBK
• UDI-Device Identifier: 07630002813532
• UDI-Public: (01)07630002813532(11)230720(240)1610060
• 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: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2026

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: 1610060
• Device Catalogue Number: 1610060
• 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: 09/01/2025
• Supplement Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/20/2023
• 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