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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SKYTRON, LLC 6500 ELITE TABLE, SURGICAL

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SKYTRON, LLC 6500 ELITE TABLE, SURGICAL Back to Search Results
Device Problems Device Inoperable (1663); Positioning Problem (3009)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/29/2016
Event Type  malfunction  
Event Description
Two buttons on the operating room table didn't work for reflex positioning for knee case. Optimal position not reached. This is an old device no longer supported by manufacturer.
 
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Brand Name6500 ELITE
Type of DeviceTABLE, SURGICAL
Manufacturer (Section D)
SKYTRON, LLC
5085 corporate exchange blvd. se.
grand rapids MI 49512
MDR Report Key6053619
MDR Text Key58275381
Report Number6053619
Device Sequence Number1
Product Code JEB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 09/30/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/25/2016
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? Yes
Date Report Sent to FDA09/30/2016
Event Location Hospital
Date Report to Manufacturer09/30/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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