MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON MEDICAL AG; HAMILTON-C3

Model Number HAMILTON-C3

Device Problems Circuit Failure (1089); Communication or Transmission Problem (2896)

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

Event Date 01/07/2021

Event Type  malfunction  

Event Description

Device is unable to recognize the communication board which result into the ventilator having a continuous alarm when connected to the facility's nurse call system.The patient was unharmed.Ventilator files will be sent via email.

Manufacturer Narrative

Since the complaint in question was submitted to hamilton medical ag almost 2 years ago, no attempts will be performed to obtain additional information.No further investigation or correction will be performed except those mentioned above.In future hamilton medical ag will report an event similar to this issue as it will be deemed a reportable event.The allegation in this complaint was confirmed to be a complaint.With this investigation it has been confirmed that the device failed to meet its specifications at the time of the event while the ventilator was in operation.The root cause was determined to be a defective mainboard and a defective communication board.In consequence the mainboard and the communication board were replaced.There was no patient or user harm.

• Brand Name: HAMILTON MEDICAL AG
• Type of Device: HAMILTON-C3
• 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: 17650398
• MDR Text Key: 322280600
• Report Number: 3001421318-2023-24486
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00730002856789
• UDI-Public: 0730002856789
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201306
• 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: 08/29/2023

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-C3
• Device Catalogue Number: 160005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2021
• Initial Date FDA Received: 08/30/2023
• 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