MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-C2

Model Number	160001
Medical Device Problem Codes	Inaccurate Flow Rate (1249); Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag`s conclusion: investigation is ongoing.
Event or Problem Description
(1) complaint description (quotation of the customer): "alarm - external flow sensor failed.Flow sensor calibration failed." (2) health impact: no clinical signs, symptoms or conditions and additional device required, were reported.
Additional Manufacturer Narrative
Additional information: hamilton medical ag comes to the following conclusion: a complaint was received with the following description: ¿alarm ¿ external flow sensor failed.Flow sensor calibration failed.¿ the following was investigated: on 20 august 2024, a flow sensor calibration was successfully for testing purposes performed.The device was then shut down and restarted on (b)(6) 2024 (date of event).Approximately 10 minutes after startup, the first ¿check flow sensor¿ message appeared, triggering sensor failure mode.Multiple ¿check flow sensor¿ alarms followed.The hamilton-c2 ventilator was placed in standby mode from pcv + mode, then the flow sensor calibration was performed.Tightness test passed.Flow sensor calibration failed twice but succeeded on the third attempt.Afterwards during ventilation with patient involvement a high-priority alarm appeared: ¿check flow sensor tubing.¿ after this calibration of the flow sensor fail, the user replaced the ventilator.Hardware analysis: cracks were found in the pressure sensor assembly during the inspection of the device.The pdiff sensor was also not providing correct values.This indicates a defective pdiff sensor (the age is over 14 years old).Root cause: a defective pressure sensor assembly and pdiff sensor was identified.
Event or Problem Description
Alarm - external flowsensor failed.Flow sensor calibration failed.

• Brand Name: HAMILTON-C2
• Common Device Name: HAMILTON-C2
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch; 8; bonaduz
• Manufacturer Contact: daniel elice ; via crusch; 8; bonaduz
• MDR Report Key: 21301341
• Report Number: 3001421318-2025-00209
• Device Sequence Number: 20852142
• Product Code: CBK
• UDI-Device Identifier: 07630002800372
• UDI-Public: (01)07630002800372(11)150625(240)160001
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121225
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2025

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: 160001
• Device Catalogue Number: 160001
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2025
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 02/04/2025
• Supplement Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/25/2015
• 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