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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY 4085 SURGICAL TABLE
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STERIS CORPORATION - MONTGOMERY 4085 SURGICAL TABLE Back to Search Results
Device Problem Malposition of Device (2616)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/12/2019
Event Type  malfunction  
Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the 4085 surgical table.The technician was unable to reproduce the reported event.No issues with function or operation of the surgical table were found.The table was returned to service.The root cause of the reported event can most likely be attributed to a button on the hand control being inadvertently pressed by user facility personnel during the procedure.A steris account manager offered in-service on the proper use and operation of the 4085 surgical table.Steris is awaiting the user facility's response.
 
Event Description
The user facility reported they felt their 4085 surgical table tilt slightly at the end of a patient procedure.The procedure was completed successfully.No report of injury.
 
Manufacturer Narrative
On july 17, 2019 a steris account manager performed in-service training on the proper use and function of the 4085 surgical table.No additional issues have been reported.
 
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Brand Name
4085 SURGICAL TABLE
Type of Device
SURGICAL TABLE
Manufacturer (Section D)
STERIS CORPORATION - MONTGOMERY
2720 gunter park drive east
montgomery AL 36109
MDR Report Key8784372
MDR Text Key151020781
Report Number1043572-2019-00055
Device Sequence Number1
Product Code FQO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 07/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Date Manufacturer Received06/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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