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

Model Number	N/A
Medical Device Problem Code	Radiation Overexposure (3017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On february 21, 2023, fujifilm healthcare americas corporation was informed of an event involving fdr go plus e.It was reported that a 6-month-old infant received one additional imaging scan at a higher exposure rate.The technician performed the initial scan at a rate of 80kv and 14 mas which was the rate used on an adult patient prior.The technician noticed that the kv and mas were incorrectly set for an infant scan and a second exposure was retaken at the corrected rate of 63kv and 1.6 mas.It is unclear if the additional exposure could lead to a safety risk.Therefore, this report is being submitted in an abundance of caution.There is no serious injury or death associated with the event.

• 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 604-8 511; JA 604-8511
• MDR Report Key: 16573944
• Report Number: 1000513161-2023-00011
• Device Sequence Number: 6127442
• Product Code: IZL
• UDI-Device Identifier: 04540217059379
• UDI-Public: (01)04540217059379(11)210408
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 03/20/2023

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: N/A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/21/2023
• Device Age: 2 YR
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/20/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown