MAUDE Adverse Event Report: ARCOMA AB FDR D-EVO II FLAT PANEL DETECTOR SYSTEM; SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)

Model Number D-EVO SUITE

Device Problem Radiation Underexposure (3018)

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

Event Date 01/17/2024

Event Type  malfunction  

Manufacturer Narrative

Comp ref (b)(4).On 17th january, 2024 fujifilm engineer went to site and tested the reported problem.He could not confirmed the reported problem.He talked with tech support and decided to order new parts.On 19th january, 2024 engineer has replaced the mpx54a board.After replacing the board, the system was rebooted and took multiple exposures without any issues.The engineer has put the system back into clinical use.

Event Description

On january 17th, 2024, fujifilm healthcare americas corporation was informed of an event involving d-evo suit.It was reported that the problem continuous issue, exposure malfunction will roto but will not expose so tech has to retake exposure.There is no patient harm or injury reported.There is no additional information provided.

• Brand Name: FDR D-EVO II FLAT PANEL DETECTOR SYSTEM
• Type of Device: SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
• Manufacturer (Section D): ARCOMA AB; annavägen 1; växjö, se 35246 ; SW 35246
• MDR Report Key: 18663635
• MDR Text Key: 334811057
• Report Number: 1000513161-2024-00008
• Device Sequence Number: 1
• Product Code: MQB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/29/2024,02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D-EVO SUITE
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/17/2024
• Event Location: Hospital
• Date Report to Manufacturer: 01/29/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/07/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1