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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHIMADZU COPORATION DAR-8000I; ANGIOGRAPHIC X-RAY SYSTEM

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SHIMADZU COPORATION DAR-8000I; ANGIOGRAPHIC X-RAY SYSTEM Back to Search Results
Device Problem Loss of Data (2903)
Patient Problems Radiation Overdose (1510); No Known Impact Or Consequence To Patient (2692)
Event Date 03/15/2017
Event Type  malfunction  
Event Description
Images were sent from dar - 8000i to pacs after fluoroscopic examination, but only one was stored in pacs.Even when checking the db of the dar - 8000i device, there was only one image.Therefore, re-examination was carried out.
 
Manufacturer Narrative
The cause of this problem was judged to be due to the fact that the facility side did not carry out periodic defragmentation instructed by the manufacturer.However, we will inform user to ensure the free space of the hard disk and defragmentation in order to avoid the probability for the similar phenomena by the user notification.See evaluation summary by manufacture (mfr report 8030233-2017-00002 follow-up#1).
 
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Brand Name
DAR-8000I
Type of Device
ANGIOGRAPHIC X-RAY SYSTEM
Manufacturer (Section D)
SHIMADZU COPORATION
1, nishinokyo kuwabara-cho
nakagyo-ku
kyoto, kyote 604-8 511
JA  604-8511
Manufacturer (Section G)
SHIMADZU CORPORATION
1, nishinokyo, kuwabara-cho
nakagyo-ku
kyoto, kyoto 604-8 511
JA   604-8511
Manufacturer Contact
toshio kadowakishimadzu corporat
1, nishinokyo, kuwabara-cho
nakagyo-ku
kyoto, kyoto 604-8-511
JA   604-8511
8231927
MDR Report Key6590061
MDR Text Key76044237
Report Number8030233-2017-00002
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
PMA/PMN Number
K052076
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Remedial Action Notification
Type of Report Initial,Followup
Report Date 07/07/2017
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 No Information
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 04/27/2017
Initial Date FDA Received05/25/2017
Supplement Dates Manufacturer Received04/27/2017
Supplement Dates FDA Received07/07/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/04/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Congenital Anomaly;
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