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 10/31/2022

Event Type  malfunction  

Event Description

Hey (b)(4), so to give more context on the event they experienced: ventilator was plugged in.The user had attached a set to the ventilator prior to turning it on.The two battery leds were illuminated before attempting to power on the ventilator.When user engaged the power button, the two battery leds went out but the screen did not turn on.Instead, a constant audible alarm was triggered and continued to sound until the user held down the power button for roughly 10 seconds.They did try using the silence alarm button but was unsuccessful.After setting aside the ventilator for roughly 2 hours, the user attempted to turn on the device and was successful.Ventilator was working as expected.I have uploaded the service logs, event logs, and error logs.Below are the answers to the questions regarding the ventilator.

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.

• 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: 18900845
• MDR Text Key: 337693507
• Report Number: 3001421318-2023-42433
• 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: 11/08/2022
• 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