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

Model Number RAPHAEL

Device Problems Display or Visual Feedback Problem (1184); Failure to Power Up (1476)

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

Event Date 10/20/2022

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 (b)(4) sites.A detailed investigation was performed by an expert from the technical service: since the complaint in question was submitted to hamilton medical ag almost 2 years 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 during the ventilator startup.Nevertheless, a clear root cause was not determined.The affected power supply board was maintained, and the issue was solved.There was no reported patient or user harm.

Event Description

The report from hospital stay: on (b)(6) 2022 the medical staff performed routine test before patient connection.After startup, the ventilator showed red screen and could not work.Raphael color made in 2011.

• Brand Name: HAMILTON MEDICAL AG
• Type of Device: RAPHAEL
• 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: 18709523
• MDR Text Key: 336524621
• Report Number: 3001421318-2023-42130
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K022679
• 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: RAPHAEL
• Device Catalogue Number: 157121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/25/2022
• 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