MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-C2

Model Number	160002
Medical Device Problem Code	Failure of Device to Self-Test (2937)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag comes to the conclusion: investigation ongoing.
Event or Problem Description
The following was reported to hamilton medical ag: summary: white display screen after start-up.
Additional Manufacturer Narrative
Hamilton medical ag comes to the conclusion: investigation ongoing.Hamilton medical ag complaint number: cer (b)(4).Follow-up 1 - corrected information: udi related data quality updates only field d4 was updated with full udi information.Updated fields.
Event or Problem Description
The following was reported to hamilton medical ag: summary: white display screen after start-up.

• Brand Name: HAMILTON-C2
• Common Device Name: HAMILTON-C2
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz, switzerland 7402 ; SZ 7402
• Manufacturer Contact: daniel elice ; via crusch 8; bonaduz, switzerland 7402 ; SZ 7402
• MDR Report Key: 18462701
• Report Number: 3001421318-2024-00020
• Device Sequence Number: 11538363
• Product Code: CBK
• UDI-Device Identifier: 07630002800730
• UDI-Public: (01)07630002800730(21)3422(11)150626(240)160002
• 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): Y
• 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): 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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2023
• Supplement Date Received by Manufacturer: 12/18/2023
• Initial Report FDA Received Date: 01/08/2024
• 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