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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHIMADZU CORP. SHIMADZU X-RAY DIAGNOSTIC TABLE YSF-300 RADIGLOGIC TABLE

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SHIMADZU CORP. SHIMADZU X-RAY DIAGNOSTIC TABLE YSF-300 RADIGLOGIC TABLE Back to Search Results
Device Problems Circuit Failure (1089); Fluid Leak (1250); Self-Activation or Keying (1557)
Patient Problems No Consequences Or Impact To Patient (2199); Not Applicable (3189)
Event Date 01/27/2017
Event Type  malfunction  
Event Description
At the diagnosis, the foot end of the table began to raise in it's own. Contrast medium were leaked on to the table and ran down the side panel around the table switch panel. There was no health hazards.
 
Manufacturer Narrative
See evaluation summary by manufacturer.
 
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Brand NameSHIMADZU X-RAY DIAGNOSTIC TABLE YSF-300
Type of DeviceRADIGLOGIC TABLE
Manufacturer (Section D)
SHIMADZU CORP.
1, nishinokyo kuwabara-cho,
nakagyo-ku
kyoto, kyoto 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 kadowaki
1, nishinokyo kuwabara-cho,
nakagyo-ku
kyoto, kyoro 604-8-511
JA   604-8511
8231305
MDR Report Key6344495
MDR Text Key68147598
Report Number8030233-2017-00001
Device Sequence Number1
Product Code IXR
Combination Product (y/n)N
PMA/PMN Number
K001809
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Remedial Action Notification
Type of Report Initial,Followup
Report Date 04/10/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
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 Received01/27/2017
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 Initial

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