MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON MEDICAL AG; HAMILTON-G5

Model Number HAMILTON-G5

Device Problem Operating System Becomes Nonfunctional (2996)

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

Event Date 09/24/2021

Event Type  malfunction  

Manufacturer Narrative

The issue in this cer is deemed as a reportable event since the malfunction 'connection panel lost' which logs different tfs and switches to ambient state during ventilation will cause the ventilator to become inoperable or stop working as intended.The root cause of the ventilator device showed many tfs in one single second and the display "panel connection lost" alarm during ventilation was due to a defective vu esm board.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 at all from complainant which should have led to further questions regarding any harm to the patient or user.As the complaint in this cer was submitted to hamilton medical ag almost 2 years ago, no attempts will be performed to obtain additional information.The allegation in this cer was confirmed to be a complaint.No further investigation or correction will be performed except those mentioned above already performed.In future hamilton medical ag will report an event similar to the issue in this cer as it will be deemed as a reportable event.

Event Description

The buzzer of the ventilator starts to sound.

• Brand Name: HAMILTON MEDICAL AG
• Type of Device: HAMILTON-G5
• 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: 17806064
• MDR Text Key: 324114596
• Report Number: 3001421318-2023-19849
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K193228
• 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: 09/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HAMILTON-G5
• Device Catalogue Number: 159001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2021
• 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