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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FUJIFILM MEDICAL SYSTEMS U.S.A., INC. FDX CONSOLE MEDICAL IMAGE PROCESSING WORKSTATION

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FUJIFILM MEDICAL SYSTEMS U.S.A., INC. FDX CONSOLE MEDICAL IMAGE PROCESSING WORKSTATION Back to Search Results
Model Number DR-ID300CL
Device Problem Improper or Incorrect Procedure or Method
Event Date 11/12/2013
Event Type  Malfunction  
Manufacturer Narrative

Fmsu submitted this mdr (along with three other mdrs) on october 6, 2015. Unfortunately, the submission failed and we did not realize it until last week. We are therefore submitting it today. The following is the acknowledgment message received on october 6, 2015: (b)(4) has received your submission. ".

 
Event Description

Fujifilm medical systems u. S. A. , inc. (fmsu) recently completed a retrospective review of complaint files from 2013 through 2015 and has determined that this complaint may meet the threshold for reporting because images were reported as lost. Fmsu is therefore reporting it at this time. The site (b)(6) reports that they have lost two images during operation of a clustered (b)(4) console running v6. 2. These images were taken between 1:00 and 1:10 pm on (b)(6) 2013. These images had become inaccessible and the (b)(4) was then rebooted. Rebooting deletes the images from the database. Once the reboot process was complete the images were no longer present on the (b)(4) console. The facility did not provide any information indicating this as an adverse event, i. E. , that the patient was re-imaged. Fujifilm therefore is considering this as a possible malfunction.

 
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Brand NameFDX CONSOLE
Type of DeviceMEDICAL IMAGE PROCESSING WORKSTATION
Manufacturer (Section D)
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
419 west avenue
stamford CT 06902
Manufacturer (Section G)
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
419 west avenue
stamford CT 06902
Manufacturer Contact
arye hess
419 west ave
stamford , CT 06902
2036023652
MDR Report Key5429299
Report Number2443168-2015-00008
Device Sequence Number1
Product CodeLLZ
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Type of Report Initial
Report Date 10/06/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/10/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device MODEL NumberDR-ID300CL
Device Catalogue NumberN/A
Device LOT NumberN/A
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/15/2013
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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