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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MIZUHO MEDICAL SKYTRON; SURGICAL TABLE
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MIZUHO MEDICAL SKYTRON; SURGICAL TABLE Back to Search Results
Model Number 6500HD
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/02/2016
Event Type  Injury  
Event Description
Response to report number mw5060086.Upon further evaluation, the facility reported that they replaced the power cord and it appears to have corrected the issue.A skytron product manager reviewed the details and there is not enough detail to conclusively determine what caused the issue.It could have been the bad power cord or something got stuck in one of the solenoids causing it to stay open.The act of moving the table could have caused enough vibration to allow the solenoid to close thereby correcting the issue.The facility informed skytron that they do have regular pms scheduled but skytron was not provided with any records.This is also an older model table that has been discontinued.The facility informed skytron that they will be replacing this table in the near future.
 
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Brand Name
SKYTRON
Type of Device
SURGICAL TABLE
Manufacturer (Section D)
MIZUHO MEDICAL
hongo shintoku bldg. 7f
3-38-1, hongo
bukyo-ku, japan 113-0 033
JA  113-0033
MDR Report Key5748547
MDR Text Key48133429
Report Number1825014-2016-00008
Device Sequence Number1
Product Code GDC
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial
Report Date 06/24/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number6500HD
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/24/2016
Distributor Facility Aware Date03/30/2016
Event Location Hospital
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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