MAUDE Adverse Event Report: SHIMADZU CORP. FUJIFILM FDR GO; MOBILE X-RAY SYSTEM

Model Number FDR GO

Device Problems Computer Software Problem (1112); Data Problem (3196)

Patient Problem No Code Available (3191)

Event Date 05/17/2015

Event Type  malfunction  

Manufacturer Narrative

The fdr go is a mobile x-ray system manufactured by shimadzu corporation for fujifilm and labeled as a "fujifilm fdr go".The fdr go's console (or workstation) uses acquisition workstation software developed by fujifilm.(b)(4) imports the fdr go into the united states.Investigation by importer has determined that a very specific (and also unexpected) sequence of steps performed when adding annotations to the image caused the issue.The issue prevented the system from transferring the image to pacs.Testing also showed that the image was still resident on the dr-id800 and that it could have been resent to pacs if the annotations had been removed.Original chest x-ray image data was remained in the product.Another chest x-ray should not have been needed.If necessary additional remedial action, it will be including in follow-up report.

Event Description

The event description as received in the user facility report ((b)(4)) was: "event desc: portable of patient.The image could not be transferred to image storage software due to a "glitch" in the software.This caused the technician to take a second image.A second similar event occurred subsequently on a subsequent date and was corrected by the software vendor with a version upgrade.Appeared problem related to annotations made on image by the technician caused file corruption." the user report classified this event as a device malfunction.Fujifilm medical systems provides the following additional information regarding the alleged event: typically portable exams are taken (in patient rooms, operating rooms, er, etc.) and transferred through the hospital network to the hospital's pacs.In this event, the creation of image annotations apparently resulted in the image not being able to be transferred to pacs.Further information from the user facility indicates the technologist performed the exam again to avoid delay.

• Brand Name: FUJIFILM FDR GO
• Type of Device: MOBILE X-RAY SYSTEM
• Manufacturer (Section D): SHIMADZU CORP.; 1,nishinokyo-kuwabaracho,; kyoto ; JA
• Manufacturer Contact: naoki morooka ; 1,nishinokyo-kuwabaracho,; nakagyoku, kyoto 607-8-511 ; JA 607-8511 ; 58231307
• MDR Report Key: 4945172
• MDR Text Key: 24596356
• Report Number: 8030233-2015-00001
• Device Sequence Number: 1
• Product Code: IZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080701
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility,Distributor
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FDR GO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR