MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON MEDICAL AG; HAMILTON-T1

Model Number HAMILTON-T1

Device Problem Failure to Power Up (1476)

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

Event Date 01/17/2023

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: this issue is deemed a reportable event since the malfunction may lead to a delay of the therapy as the device has to be re-started.The root cause could not be identified since the startup issue is not reproducible.Within this investigation it has been confirmed that the device failed to meet its specifications at the time of the event.There was no patient or user harm.The allegation in this complaint 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 similar to this issue as it will be deemed a reportable event.

Event Description

Customer goes to turn on vent and ventilator alarms with black screen.Will alarm until vent turned off (holding power for up to 20seconds) or batteries removed.Unit will start up just fine the second time.This happened to two seperate vents (logs only available for 1).

• Brand Name: HAMILTON MEDICAL AG
• Type of Device: HAMILTON-T1
• 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: 18900880
• MDR Text Key: 337739917
• Report Number: 3001421318-2023-41145
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00730002856789
• UDI-Public: 0730002856789
• Combination Product (y/n): N
• PMA/PMN Number: K181216
• 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: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HAMILTON-T1
• Device Catalogue Number: 161006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2023
• 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