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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/Blood 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 Name
SHIMADZU X-RAY DIAGNOSTIC TABLE YSF-300
Type of Device
RADIGLOGIC 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 Other
Remedial Action Notification
Type of Report Initial,Followup
Report Date 04/10/2017
1 Device was Involved in the Event
1 Patient was 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 No Information
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
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
Patient Sequence Number1
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