MAUDE Adverse Event Report: FUJIFILM CORPORATION FDR D-EVO SUITE II; FLAT PANEL DIGITAL DETERCTOR

Model Number DR-ID600

Device Problem Radiation Overexposure (3017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/08/2019

Event Type  malfunction  

Manufacturer Narrative

An on-site customer service engineer (cse) visited the customer site and determined that the device functioned as intended and the issue of high dose was due to user error.Discussion with the user revealed that they decided to perform the exposure with the panel in free mode, where the panel is placed on the tabletop and not in the table bucky.The pediatric patient was then positioned at the foot of the bed to perform the exposure.When the free selector was pressed, the generator console displayed error 0916; error 916 is a warning that a photo timed exposure can't be accomplished with the panel on the tabletop.To continue the procedure, the "m" button on the generator console was pressed by the user.After the m button was pressed, the generator console was left in table bucky state, with photo timing for exposure mode still active.When the user positioned the tube above the foot of the bed, there was approximately 30-36 inches of distance from the exposure point to the photo timing cell; when exposing in this condition there was enough scatter dose to satisfy the photo timer circuit to allow the exposure to continue, but not enough dose to terminate the exposure in the appropriate time for this study.There was no malfunction with the devices involved in this event; the re-imaging and high dose was due to user incorrect technique.If any additional relevant information is provided, a supplemental report will be submitted.

Event Description

During a service call for an issue related to image artifacts, fujifilm medical systems usa (fmsu) was informed that a patient was re-imaged three (3) additional times; the anatomy being radiated was the sacrum coccyx.The customer informed fmsu that the technique values were entered manually by the radiology technician and were not verified prior to exposing the patient.The technique values were 80 kvp/271 mas and 80 kvp/258 mas and sid 40cm.The re-exposures were performed in a room equipped with a d-evo suite comprised of devo panel, console, table and x-ray tube and generator.The customer mentioned that there were no signs of serious injuries associated as a result of the re-exposures.After the two exposures were performed the customer sent the patient to another location to finish the exam.This event is being reported in an abundance of caution due to the exposure dose and age of the patient.There was no patient death or serious injury associated with this event.

• Brand Name: FDR D-EVO SUITE II
• Type of Device: FLAT PANEL DIGITAL DETERCTOR
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 00258 8538; JA 002588538
• Manufacturer (Section G): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 00258 8538; JA 002588538
• Manufacturer Contact: safety officer ; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 00258-8538 ; JA 002588538
• MDR Report Key: 8601204
• MDR Text Key: 203662163
• Report Number: 3001722928-2019-00006
• Device Sequence Number: 1
• Product Code: MQB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100762
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/10/2019

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
• Device Operator: Health Professional
• Device Model Number: DR-ID600
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/15/2019
• Initial Date FDA Received: 05/10/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/08/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 8 MO
• Patient Weight: 5