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

Model Number FDR GO

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 06/17/2017

Event Type  Death  

Event Description

Fujifilm medical systems u.S.A., inc.Received a request for service to the technical assistance center on saturday (b)(6) 2017 regarding the fdr go mobile x-ray unit at hospital facility.During the call, the complainant told the customer support representative that there had been an incident at the hospital on or before (b)(6) where a failure of the fdr go had resulted in the death of a child.On tuesday, (b)(6), fujifilm medical systems u.S.A., inc.Contacted the dept of radiology at the hospital in order to better understand the incident, determine if a patient injury or death occurred, and obtain a copy of the incident report from the hospital.The manager of dept of radiology responded via email on tuesday, (b)(6) that " the system (fujifilm fdr go portable) did not fail during this event and the outcome was not attributed to the unit or the tech.".

Event Description

This supplemental report is being submitted on 08/31/2017 for the initial mdr, 2443168-2017-00002, submitted on 7/17/2017 in an abundance of caution.The information in this supplemental report supersedes and corrects any information previously reported to the fda by fmsu for the mdr, 2443168-2017-00002.Fujifilm medical systems u.S.A., inc.(fmsu) has been unable to discover any patient injury or death associated with the reported incident.Fmsu has concluded that the fdr go was not involved in this reported incident.Sat (b)(6) 2017: fujifilm medical systems u.S.A., inc.(fmsu) technical assistance center (tac) received a service request call from the hospital regarding a failure to transfer images between fdr go and the hospitals pacs system due to issues with wi-fi connectivity between the fdr go and the hospital pacs system.During the call, fmsu received a complaint of a patient death or injury where the complainant claimed that the loss of connectivity between fdr go and the hospital pacs system was a causal factor.No further information on the reported incident was shared by the complainant with the fmsu tac representative during the call.Mon june 19, 2017: fmsu attempted to contact the complainant and the administrative director of radiology of the hospital to determine if, when and under what circumstances the reported incident had taken place, and if the hospital had filed or was planning to file an mdr with the fda? but fmsu could not identify a patient injury or death associated with the fdr go.Tue june 20, 2017: fmsu received an email response from the administrative director of radiology of the hospital stating the following."the system (fujifilm fdr go portable) did not fail during this event and the outcome was not attributed to the unit or the tech.".Subsequently, fmsu continued to attempt to contact the complainant on a number of occasions between june 20 and june 24 but did not receive any response.There is no evidence that fmsu was able to discover that an incident occurred on or around (b)(6) 2017 at the hospital where a patient injury or death occurred and the failure of the fdr go may have been a casual factor.The investigation was closed on june 28, 2017 with no evidence that a patient had been injured or died due to a problem or issue with an fdr go at the hospital.This is a first supplemental report for the initial mdr, 2443168-2017-00002, submitted on 7/17/2017 and the information in this supplemental report supersedes and corrects any information previously reported to the fda by fmsu for the mdr, 2443168-2017-00002.

• Brand Name: FDR GO
• Type of Device: MOBILE X-RAY SYSTEM
• Manufacturer (Section D): SHIMADZU CORPORATION; 1, nishinokyo, kuwabara-cho,; nakagyo-ku,; kyoto, 604-8 511; JA 604-8511
• MDR Report Key: 6719677
• MDR Text Key: 80247802
• Report Number: 2443168-2017-00002
• Device Sequence Number: 1
• Product Code: IZL
• UDI-Device Identifier: 04540217053438
• UDI-Public: 04540217053438
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/17/2017,08/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FDR GO
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/17/2017
• Distributor Facility Aware Date: 06/17/2017
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/08/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death