MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-C2

Model Number	160002
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag comes to the conclusion: root cause: investigation ongoing.Corrected the product type.It is hamilton-c2 not hamilton-c6.
Event or Problem Description
The following was reported to hamilton medical ag: summary: unit doesn't start up.
Additional Manufacturer Narrative
Hamilton medical ag comes to the conclusion: root cause: investigation ongoing.
Event or Problem Description
The following was reported to hamilton medical ag: summary: unit doesn't start up.
Additional Manufacturer Narrative
Hamilton medical ag comes to the conclusion: additional information: root cause: the most likely root cause related to this event is a defective esm board.Incident summary: during the startup of the machine, a self-test failure alarm was reportedly triggered.However, after performing a restart, the machine returned to normal operating conditions.Follow-up action: on 11.07.2024, a service technician conducted a thorough examination of the device.The test report issued by the technician confirmed that no technical problems were observed during the post-event testing.Conclusion: at the time of inspection, the device passed all tests successfully and was cleared for use.It has since been returned to its intended operational environment within the hospital.Corrected information: d1, d2a, d4.
Event or Problem Description
The following was reported to hamilton medical ag: summary: unit doesn't start up.
Event or Problem Description
The following was reported to hamilton medical ag: summary: unit doesn't start up.
Additional Manufacturer Narrative
Hamilton medical ag comes to the conclusion: additional information: root cause: the most likely root cause related to this event is a defective esm board.Incident summary: during the startup of the machine, a self-test failure alarm was reportedly triggered.However, after performing a restart, the machine returned to normal operating conditions.Follow-up action: on 11.07.2024, a service technician conducted a thorough examination of the device.The test report issued by the technician confirmed that no technical problems were observed during the post-event testing.Conclusion: at the time of inspection, the device passed all tests successfully and was cleared for use.It has since been returned to its intended operational environment within the hospital.Corrected information.Hamilton medical ag complaint number: cer (b)(4).Follow-up 3 - corrected information: udi related data quality updates only field d4 was updated with full udi information.Updated fields.

• Brand Name: HAMILTON-C2
• Common Device Name: HAMILTON-C2
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz, switzerland 7402 ; CH 7402
• Manufacturer Contact: daniel elice ; via crusch 8; bonaduz, switzerland 7402 ; SZ 7402
• MDR Report Key: 19378964
• Report Number: 3001421318-2024-01273
• Device Sequence Number: 15375776
• Product Code: CBK
• UDI-Device Identifier: 07630002800730
• UDI-Public: (01)07630002800730(21)13226(11)180309(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): Y
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,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: 05/14/2024
• Supplement Date Received by Manufacturer: 05/14/2024; 10/16/2024; 10/16/2024
• Initial Report FDA Received Date: 05/23/2024
• Supplement Report FDA Received Date: 05/23/2024; 11/05/2024; 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/09/2018
• 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