MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON MEDICAL AG; HAMILTON-C6

Model Number HAMILTON-C6

Device Problem No Visual Prompts/Feedback (4021)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/10/2022

Event Type  malfunction  

Manufacturer Narrative

In this case the ventilation continued, and the connection loss only concerned the interaction panel (ip).This type of failure (tn 556951 and tn 556952 ) "panel connection lost" has been reduced by various hardware and software improvements.The biggest effect on the failure rate was achieved by software update 1.2.1.Therefore, this failure is considered a software failure.The failure has not yet been fully fixed.Reoccurrence is still possible.Before this software fix was available the only action which could be done in the field was by replacing hardwareparts, which solved the failure in the short term.The root cause / the replaced hardware components may differe between each cases.However they can all be linked to the same issue.Within this investigation it has been confirmed that the device failed to meet its specifications at the time of the event while it was used for treatment or diagnosis.There was no patient or user harm reported from the complainant which should have led to further questions regarding any harm to the patient or user.The allegation in this case was confirmed to be a complaint.No further investigation or correction will be performed except those mentioned above.In future hamilton medical ag will report an event like the issue in this case as it will be deemed a reportable event.

Event Description

Dear sven this unit had a black screen issue.In our tests we have found that there were no screws securing the ip esm.Due to that the unit had a black screen.We have installed new screws , the unit passed all tests & run.Please advise if we can send this unit back to work.Br lior.

• Brand Name: HAMILTON MEDICAL AG
• Type of Device: HAMILTON-C6
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz, 7402 ; SZ 7402
• Manufacturer Contact: andre sonnenberg ; via crusch 8; bonaduz, graubunden 7402 ; SZ 7402
• MDR Report Key: 17592502
• MDR Text Key: 321632469
• Report Number: 3001421318-2023-12568
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00730002856789
• UDI-Public: 0730002856789
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K201658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/21/2023

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
• Device Operator: Health Professional
• Device Model Number: HAMILTON-C6
• Device Catalogue Number: 160021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1