MAUDE Adverse Event Report: SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION FDR GO PLUS E; SYSTEM, X-RAY, MOBILE

Model Number	FDR GO PLUS E
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
On april 16th, 2025, fujifilm healthcare americas corporation was informed of an event involving fdr go plus e.The issue was that the plug may not be grounded, sparking inside of clear housing and causing the plug to heat up.The injury to the user or any patient involvement has not been confirmed at this time.This report is being submitted in an abundance of caution.
Additional Manufacturer Narrative
Ref comp # (b)(4).The resolution was to rebuild the plug on the cord reel, test the plug and charging circuit, which tested good.The unit is working as designed.

• Brand Name: FDR GO PLUS E
• Common Device Name: SYSTEM, X-RAY, MOBILE
• Manufacturer (Section D): SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION; 1,nishinokyo-kuwabaracho; nakagyoku, kyoto 64085 11; JA 6408511
• MDR Report Key: 22035997
• Report Number: 1000513161-2025-00018
• Device Sequence Number: 9411671
• Product Code: IZL
• UDI-Device Identifier: 04540217059379
• UDI-Public: (01)04540217059379(11)191017
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/16/2025

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
• Operator of Device: Health Professional
• Device Model Number: FDR GO PLUS E
• 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: 04/16/2025
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/16/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown