MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-C2; (ALARM BLOWER SPEED LOW

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	01/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag`s conclusion: the root-cause for event was a defective blower module, specifically in this case the blower speed was lower than the required speed.The correction in this case has been the replacement of the blower module.The device issue was solved.
Event or Problem Description
Hamilton medical ag received the following complaint description (quotation of the customer/reporter): "- te 231009 (alarm blower speed low) - blower flow test failed - blower pressure test failed - blower module assembly replaced." no health impact or consequences were reported.

• Brand Name: HAMILTON-C2
• Common Device Name: (ALARM BLOWER SPEED LOW
• 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: 21372453
• Report Number: 3001421318-2025-00290
• Device Sequence Number: 3849781
• Product Code: CBK
• UDI-Device Identifier: 07630002800372
• UDI-Public: (01)07630002800372(11)150629(240)160001
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 02/13/2025

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: 01/30/2025
• Initial Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/29/2015
• 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