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	Installation-Related Problem (2965)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ref comp (b)(4).
Event or Problem Description
On (b)(6) 2024 fujifilm healthcare americas corporation was informed of an event involving fdr go plus e.It was reported that the peds abdomen is defaulting to adult abdomen techniques.There is no additional information provided.

• 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: 19091213
• Report Number: 1000513161-2024-00025
• Device Sequence Number: 20746192
• Product Code: IZL
• UDI-Device Identifier: 04540217059379
• UDI-Public: (01)04540217059379(11)180911
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/11/2024
• Report Date (Section F): 04/11/2024

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
• Operator of Device: Other
• Device Model Number: FDR GO PLUS E
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/27/2024
• Event Location: Hospital
• Date Report to Manufacturer: 04/11/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/11/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown