MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-C2

Model Number	160001
Medical Device Problem Code	Decrease in Pressure (1490)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This complaint is reportable because it involves a ventilator malfunction related to the blower, a critical component for maintaining proper ventilation.The occurrence of technical event 231009, "blower controller speed low," triggered a high-priority alarm during ventilation, indicating a potential risk of ventilation failure.The need for a blower replacement suggests a possible issue that could compromise patient safety, making this event reportable.The corrective action in this case was the replacement of the blower module (pn: 160250), which resolved the issue.The root cause of the event was identified as a defective blower module.
Event or Problem Description
Complaint description quotation of the customer/reporter: "technical event: 231009 ("blower controller speed low"), blower test failed.".

• Brand Name: HAMILTON-C2
• Common Device Name: HAMILTON-C2
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch,; 8; bonaduz 7402 ; SZ 7402
• Manufacturer Contact: daniel elice ; via crusch; 8; bonaduz 7402 ; SZ 7402
• MDR Report Key: 21311492
• Report Number: 3001421318-2025-00223
• Device Sequence Number: 15679359
• Product Code: CBK
• UDI-Device Identifier: 07630002800372
• UDI-Public: (01)07630002800372(11)170911(240)160001
• Combination Product (Y/N): N
• Initial Reporter Country: LO
• 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
• Report Date (Section B): 02/05/2025

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: 01/29/2025
• Initial Report FDA Received Date: 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/11/2017
• 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