MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-C2

Model Number	160002
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The following was reported to hamilton medical ag: summary: unit is longer transmitting data to the capsule.Noticed the rs 232 connection board on the c2 is loose/no longer making full contact to the control board.
Additional Manufacturer Narrative
Hamilton medical ag comes to the conclusion: investigation ongoing.Note: the udi number in section d4 will be provided in the follow-up report, as it is currently being internally verified for this product variant.
Event or Problem Description
The following was reported to hamilton medical ag: summary: unit is longer transmitting data to the capsule.Noticed the rs 232 connection board on the c2 is loose/no longer making full contact to the control board.
Additional Manufacturer Narrative
Hamilton medical ag comes to the conclusion: 09.August 2024: correction in d4: model number and catalog number 160002 (correct) instead 160001 (incorrect).Investigation still ongoing.Note: the udi number in section d4 will be provided in the next follow-up report, as it is currently being internally verified for this product variant.
Additional Manufacturer Narrative
Hamilton medical ag comes to the conclusion: 09.August 2024: correction in d4: model number and catalog number 160002 (correct) instead 160001 (incorrect).Investigation still ongoing.Note: the udi number in section d4 will be provided in the next follow-up report, as it is currently being internally verified for this product variant.Follow-up 2 - additional information: the entry fields b4, d4, g6, h2, h6 and h11 have been updated.It was reported that the unit was no longer transmitting data to the capsule system.Upon inspection, it was found that the rs-232 connection board on the hamilton-c2 device was loose and no longer making full contact with the control board.No patient involvement and consequently no clinical consequences were reported.To address the issue, a replacement mainboard was shipped to the customer.No log files were provided for analysis, and no feedback was received confirming whether the replacement resolved the issue.Although the outcome could not be verified, it is assumed that the issue was resolved by replacing the mainboard, as no further issues have been reported.
Event or Problem Description
The following was reported to hamilton medical ag: summary: unit is longer transmitting data to the capsule.Noticed the rs 232 connection board on the c2 is loose/no longer making full contact to the control board.

• 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: 19926218
• Report Number: 3001421318-2024-01857
• Device Sequence Number: 14148647
• Product Code: CBK
• UDI-Device Identifier: 07630002800730
• UDI-Public: (01)07630002800730(11)150626(240)160002
• 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,Followup
• Report Date (Section B): 07/31/2025

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
• 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: 07/29/2024
• Supplement Date Received by Manufacturer: 07/29/2024; 07/29/2024
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 08/09/2024; 07/31/2025
• 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