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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SKYTRON, INC. TABLE, SURGICAL

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SKYTRON, INC. TABLE, SURGICAL Back to Search Results
Model Number 6500N
Device Problem Unintended Movement (3026)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/01/2017
Event Type  malfunction  
Event Description
The or table slowly drifted down while the patient was on the table, although the or staff did not select this function. The surgical technician unplugged the unit from the electrical outlet, reinserted plug, and the unit resumed normal operation.
 
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Type of DeviceTABLE, SURGICAL
Manufacturer (Section D)
SKYTRON, INC.
5085 corporate exchange blvd se
grand rapids MI 49512
MDR Report Key7074353
MDR Text Key93492955
Report Number7074353
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
Type of Report Initial
Report Date 11/14/2017,11/15/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/01/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number6500N
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/14/2017
Device Age23 YR
Event Location Hospital
Date Report to Manufacturer11/14/2017
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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