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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SKYTRON TABLE, OPERATING ROOM / BEACH CHAIR ATTACHMENT
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SKYTRON TABLE, OPERATING ROOM / BEACH CHAIR ATTACHMENT Back to Search Results
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/13/2017
Event Type  Injury  
Event Description
Pt scheduled for arthroscopic irrigation and debridement left shoulder.In operating room, pt was put in beach chair position with arthrex beach chair attachment with his head in head holder.Blood pressure dropped.Skytron operating room table was moved to trendelenburg position and blood pressure was treated.After blood pressure increased, attempt was made to level bed so pt could be positioned for surgery.During leveling process, the beach chair attachment of the operating room table became detached from the main portion of the operating room table while the pt was attached to it.The staff in the room were able to immediately support the pt's upper body when this occurred.Precautions were immediately implemented and testing was completed to ensure pt was not injured.After the testing confirmed that pt was not injured and that it was safe to proceed, the shoulder surgery was completed the same day.Root cause analysis completed.
 
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Brand Name
TABLE, OPERATING ROOM / BEACH CHAIR ATTACHMENT
Type of Device
BEACH CHAIR ATTACHMENT
Manufacturer (Section D)
SKYTRON
MDR Report Key6996124
MDR Text Key90983915
Report NumberMW5073101
Device Sequence Number1
Product Code FQO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Attorney
Type of Report Initial
Report Date 10/31/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/02/2017
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age78 YR
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