MAUDE Adverse Event Report: SHIMADZU COPORATION FDR GO; SYSTEM, X-RAY, MOBILE

Medical Device Problem Codes	Installation-Related Problem (2965); No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On april 12, we were notified by the importer of the device, fujifilm healthcare americas, that it had submitted an mdr (report no: 1000513161-2024 00025) to the fda with the following information: on march 27th 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.".
Additional Manufacturer Narrative
Detailed information is being collected due to lack of information.After obtaining additional information, we will consider the need for action.
Event or Problem Description
On april 12, we were notified by the importer of the device, fujifilm healthcare americas, that it had submitted an mdr (report no: (b)(4)) to the fda with the following information: "on march 27th 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.".
Additional Manufacturer Narrative
In paragraph f10 of mdr (mdr no.: (b)(4)) submitted by importer, medical device problem code (a): 2965 is defined as follows: installation-related problem problem associated with unsatisfactory installation, configuration, and/or setup of a specific device.We asked fujifilm what kind of problems occurred during installation and why they led us to report this mdr, but we could not confirm the details.However, they were able to confirm that the default adult parameters had been changed before use and that children were not photographed under adult x-ray conditions.Judging from the available information, there is no "pediatric abdomen" in the factory shooting menu, so it is probable that appropriate changes were not made when the new menu was created by modifying the other menus.We assume that this is related to the installation-related problem selected in the medical device problem code (a) of mdr.In the section on how to set apr (anatomical programs: (program for storing x-ray condition)) in the reference guide, it is stated that "when delivered, initial setting of apr is registered.Change the setting suitably in accordance with the radiography parameters often used by clinical." since the user noticed that the x-ray conditions were not appropriate before x-ray irradiation and the equipment did not malfunction, it is judged that no action is necessary for the equipment.

• Brand Name: FDR GO
• Common Device Name: SYSTEM, X-RAY, MOBILE
• Manufacturer (Section D): SHIMADZU COPORATION; 1, nishinokyo kuwabara-cho,; nakagyo-ku; kyoto, 60485 11; JA 6048511
• Manufacturer (Section G): SHIMADZU COPORATION; 1, nishinokyo kuwabara-cho,; nakagyo-ku; kyoto, 60485 11; JA 6048511
• Manufacturer Contact: takeshi yamamoto ; 1, nishinokyo kuwabara-cho,; nakagyo-ku; kyoto, 60485-11 ; JA 6048511
• MDR Report Key: 19276059
• Report Number: 8030233-2024-00002
• Device Sequence Number: 12677522
• Product Code: IZL
• UDI-Device Identifier: 04540217059379
• UDI-Public: (01)04540217059379(11)180911
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K080701
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2024

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2024
• Supplement Date Received by Manufacturer: 04/12/2024
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown