MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON MEDICAL AG; GALILEO

Model Number GALILEO

Device Problem Failure to Power Up (1476)

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

Event Date 09/15/2022

Event Type  malfunction  

Event Description

Smoke from the psu, the device did not start.

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 over 2 years ago, no attempt will be made 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 during device start-up.The root cause of this issue on a galileo unit was determined to be due to the voltage drop being higher than 150mv from the power supply to the control board.The reason for this problem is because the contact resistance is too high.There was no patient or user harm.Hamilton fm 653570 rev.00 page 7 of 8 medical complaint investigation report (remediation) complaint nr.(b)(4).

• Brand Name: HAMILTON MEDICAL AG
• Type of Device: GALILEO
• 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: 18709546
• MDR Text Key: 336184601
• Report Number: 3001421318-2023-41951
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: HU
• PMA/PMN Number: K080181
• 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: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GALILEO
• Device Catalogue Number: 155069
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2022
• 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