MAUDE Adverse Event Report: SIEMENS HEALTHINEERS FDR D-EVO SUITE II; SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)

Model Number D-EVO SUITE II

Device Problem Radiation Output Problem (4026)

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

Event Date 01/30/2024

Event Type  malfunction  

Event Description

On january 30th 2024, fujifilm healthcare americas corporation was informed of an event involving d-evo suite ii.It was reported via email about an issue noting that the light field does not match the x-ray field in your x-ray imaging system devo suite ii, necessitating an increase in radiation dose.There is no patient harm or injury reported.There is no additional information provided.

Manufacturer Narrative

Comp ref (b)(4).

• Brand Name: FDR D-EVO SUITE II
• Type of Device: SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
• Manufacturer (Section D): SIEMENS HEALTHINEERS; 91301 forchheim,; deutschland, ; GM
• MDR Report Key: 18744059
• MDR Text Key: 335816232
• Report Number: 1000513161-2024-00012
• 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: 02/08/2024,02/20/2024

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 Model Number: D-EVO SUITE II
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/30/2024
• Event Location: Other
• Date Report to Manufacturer: 02/08/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/20/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1