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	Unstable (1667)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On march 13, 2023, fujifilm healthcare americas corporation was informed of an event involving fdr go plus e.It was reported that the screws on the collimator ring are becoming loose over time causing the collimator to become unstable.There is no patient involvement or report of serious injury or death associated with the event.Therefore, this report is being submitted in abundance of caution.

• 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: 16629270
• Report Number: 1000513161-2023-00016
• Device Sequence Number: 5268826
• Product Code: IZL
• UDI-Device Identifier: 04540217059379
• UDI-Public: (01)04540217059379(11)210419
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/28/2023

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: 03/13/2023
• Device Age: 2 YR
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/28/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown