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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY 3085SP SURGICAL TABLE
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STERIS CORPORATION - MONTGOMERY 3085SP SURGICAL TABLE Back to Search Results
Device Problem Positioning Problem (3009)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/09/2015
Event Type  No Answer Provided  
Event Description
The user facility reported during a patient procedure their 3085sp surgical table would not raise upward.No report of injuries or procedural delays or cancellations.
 
Manufacturer Narrative
A steris field service technician arrived onsite, inspected the unit, and was able to duplicate the reported event; the table would not raise when commanded.The technician replaced the motor/pump assembly and added hydraulic fluid.The technician tested the table, confirmed it to be operating according to specification, and returned it to service.
 
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Brand Name
3085SP 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
kathryn cadorette
5960 heisley road
mentor, OH 44060
4403927231
MDR Report Key4491468
MDR Text Key17577296
Report Number1043572-2015-00011
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
Type of Report Initial
Report Date 02/06/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Date Manufacturer Received01/09/2015
Was Device Evaluated by Manufacturer? Yes
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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