MAUDE Adverse Event Report: SHIMADZU CORPORATION 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  

Event Description

The event description as received in the user facility report (b)(4) was: "event desc: portable unit was used to obtain portable diagnostic chest image of pt.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 info regarding the alleged event: typically portable exams are taken (in pt 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 info from the user facility indicates the technologist performed the exam again to avoid delay.

Manufacturer Narrative

The fdr go is a mobile x-ray system manufactured by shimadzu corporation fo fujifilm and labeled as a "fujifilm fds go".The fdr go's console (operating room workstation) uses acquisition workstation software developed by fujifilm.Fujifilm medical systems u.S.A., inc.(fmsu) imports the fdr go into the united states.Fmsu is completing and submitting this medwatch form as the importer.However, we have also included info regarding (b)(4) as the mfr so that all available relevant info is contained in this one report.

• Brand Name: FUJIFILM FDR GO
• Type of Device: MOBILE X-RAY SYSTEM
• Manufacturer (Section D): SHIMADZU CORPORATION; 1, nishinokyo-kuwabaracho; kyoto 604- 8511; JA 604-8511
• Manufacturer Contact: naoki morooka ; 1, nishinokyo kuwabaracho, nakagkyo-ku; kyoto 607-8-511 ; JA 607-8511 ; 58231307
• MDR Report Key: 4937998
• MDR Text Key: 6255128
• Report Number: 2443168-2015-00003
• 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: Distributor
• Source Type: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2015
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/22/2015
• Distributor Facility Aware Date: 06/22/2015
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/22/2015
• 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