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

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).

• 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 Key: 6590061
• MDR Text Key: 76044237
• Report Number: 8030233-2017-00002
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• PMA/PMN Number: K052076
• Number of Events Reported: 1
• 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 Received: 05/25/2017
• Supplement Dates Manufacturer Received: 04/27/2017
• Supplement Dates FDA Received: 07/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Congenital Anomaly