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	03/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The following was reported to hamilton medical ag: summary: blank display due to defective esm board.
Additional Manufacturer Narrative
Hamilton medical ag comes to the conclusion: root cause: defective esm board.Correction: replace esm board.
Additional Manufacturer Narrative
Hamilton medical ag comes to the conclusion: root cause: the screen crashed due to loose wiring and after the wiring was reconnected, it was normal.This defect was a problem with improper maintenance, and the ventilator itself had no defect.In addition, the machine was made in 2015 and has far exceeded its service life by the time it was used.Now, the hospital is going to scrap the machine.In summary, this event was unrelated to the quality of the product.We suggest that the hospital carry out maintenance on the machines every year, and check their wirings.Correction: the screen was normal after the wiring was reconnected.Reason for not taking control actions: 1.This defect was a problem with improper maintenance and had nothing to do with the product.2.Hamilton-c2 has been discontinued.3.Our agent's engineer visits the hospital regularly to solve problems in a timely manner, so as to ensure normal use of the machine.4.The problem was found during the preoperational check and the machine was not connected to the patient, so no injury was caused to the patient.Similar problems can always be found through the check before patient connection.The machine will be suspended from use timely.The event is unlikely to cause injury and belongs to "the event unlikely to cause death or injury".Therefore, this event does not meet the definition of the adverse event, and does not need to be reported as an adverse event.In summary, no control actions are required.
Event or Problem Description
The following was reported to hamilton medical ag: summary: blank display due to defective esm board.
Additional Manufacturer Narrative
Hamilton medical ag comes to the conclusion: root cause: the screen crashed due to loose wiring and after the wiring was reconnected, it was normal.This defect was a problem with improper maintenance, and the ventilator itself had no defect.In addition, the machine was made in 2015 and has far exceeded its service life by the time it was used.Now, the hospital is going to scrap the machine.In summary, this event was unrelated to the quality of the product.We suggest that the hospital carry out maintenance on the machines every year, and check their wirings.Correction: the screen was normal after the wiring was reconnected.Reason for not taking control actions: 1.This defect was a problem with improper maintenance and had nothing to do with the product.2.Hamilton-c2 has been discontinued.3.Our agent's engineer visits the hospital regularly to solve problems in a timely manner, so as to ensure normal use of the machine.4.The problem was found during the preoperational check and the machine was not connected to the patient, so no injury was caused to the patient.Similar problems can always be found through the check before patient connection.The machine will be suspended from use timely.The event is unlikely to cause injury and belongs to "the event unlikely to cause death or injury".Therefore, this event does not meet the definition of the adverse event and does not need to be reported as an adverse event.In summary, no control actions are required.Hamilton medical ag complaint number: cer follow-up 2 - 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: blank display due to defective esm board.

• 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: 18990074
• Report Number: 3001421318-2024-00766
• Device Sequence Number: 7540256
• Product Code: CBK
• UDI-Device Identifier: 07630002800730
• UDI-Public: (01)07630002800730(21)10019(11)150126(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
• 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: 03/19/2024
• Supplement Date Received by Manufacturer: 07/01/2024; 07/01/2024
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 07/11/2024; 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/26/2015
• 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