MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-C1

Model Number	160002
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag case number is: (b)(4).
Event or Problem Description
The following was reported to hamilton medical ag: the report from hospital say: frequent alarm of reversal of flow sensor, normal direction of flow sensor connection.No health consequences or impact.Unknown if patient involvement.
Additional Manufacturer Narrative
Hamilton medical ag case number is: (b)(4).Hamilton medical ag complaint number: (b)(4).Follow-up 1 - corrected information: **udi related data quality updates only** field d4 was updated with full udi information.Updated fields: b4, d1, d2a, d3, d4, g6, h2, h4, h5, h11.
Event or Problem Description
The following was reported to hamilton medical ag: the report from hospital say: frequent alarm of reversal of flow sensor, normal direction of flow sensor connection.No health consequences or impact.Unknown if patient involvement.

• Brand Name: HAMILTON-C1
• Common Device Name: HAMILTON-C1
• 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: christof mueller ; via crusch 8; bonaduz, 7402 ; SZ 7402
• MDR Report Key: 19018907
• Report Number: 3001421318-2024-00816
• Device Sequence Number: 15452122
• Product Code: CBK
• UDI-Device Identifier: 07630002800730
• UDI-Public: (01)07630002800730(11)150626(240)160002
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2024

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: 160002
• Device Catalogue Number: 160002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2024
• Supplement Date Received by Manufacturer: 03/28/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/26/2015
• 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