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

Model Number HAMILTON-C6

Device Problem Gas Output Problem (1266)

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

Event Date 02/24/2023

Event Type  malfunction  

Manufacturer Narrative

The complaint has been reopened and reviewed according to fda form 483 inspectional observation ems #2, eobs2 from the fda inspection conducted between july 17 to july 21, 2022 at the ems and bonaduz sites.A detailed investigation was performed by an expert from the technical service: since the complaint in question was submitted to hamilton medical ag more than one year 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 use.The root cause was determined to be a clogged/obstructed filter due to the therapy settings.There was no patient or user harm reported.For annex c the investigator chose 4253 - blockage identified.This code is not yet available in the esubmitter.Therefore the annex c field remains empty but the code will be marked here in the conclusion.

Event Description

The user said that the alarm: 'obstructed' was on the screen and they decided to retire the device, turn it off and use a backup c6.When i went to check the unit, it does not start.It takes a lot of time iniciating the unit and finally starts alarming with a red light.I attach a video.I also attach the instrument report that i got from the last preventive maintenance on 09.22.

• 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: 18911530
• MDR Text Key: 337741070
• Report Number: 3001421318-2023-40346
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00730002856789
• UDI-Public: 0730002856789
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• 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
• Date Manufacturer Received: 02/24/2023
• Was Device Evaluated by Manufacturer?: No
• 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