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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY 5085 SURGICAL TABLE

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STERIS CORPORATION - MONTGOMERY 5085 SURGICAL TABLE Back to Search Results
Device Problem Unintended System Motion (1430)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/20/2021
Event Type  malfunction  
Event Description
The user facility reported that during a patient procedure their 5085 surgical table tilted down and to the left in the head direction without being commanded to do so.The procedure was completed successfully.No report of injury.
 
Manufacturer Narrative
A steris service technician arrived onsite to inspect the table and found it to be operating properly.The reported event could not be duplicated; no repairs were required, and the table was returned to service.The table was installed in 2018 and is not under steris service agreement; the user facility is responsible for all maintenance activities.No additional issues have been reported.
 
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Brand Name
5085 SURGICAL TABLE
Type of Device
SURGICAL TABLE
Manufacturer (Section D)
STERIS CORPORATION - MONTGOMERY
2720 gunter park drive east
montgomery AL 36109
Manufacturer (Section G)
STERIS CORPORATION - MONTGOMERY
2720 gunter park drive east
montgomery AL 36109
Manufacturer Contact
daniel davy
5960 heisley road
mentor, OH 44060
4403927453
MDR Report Key13253332
MDR Text Key286640222
Report Number1043572-2022-00008
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 Manufacturer
Source Type User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/13/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/20/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/06/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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