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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 Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/12/2014
Event Type  No Answer Provided  
Event Description
The user facility reported that during a patient procedure hospital personnel commanded the back section of the table to rise and the hand control displayed an error for the kidney bridge sensor.No injuries or procedural delays or cancellations were reported.
 
Manufacturer Narrative
A steris service technician inspected the table and found that the kidney bridge sensor was out of adjustment.The technician lubricated the kidney bridge linkage, adjusted the sensor switch and performed calibration to the table.The table was confirmed operational and was returned to service.No additional issues have been reported.The table was installed on 6/9/2011 and is serviced and maintained by the user facility.
 
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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
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 Key4323647
MDR Text Key21777645
Report Number1043572-2014-00138
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 12/11/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2014
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
Date Manufacturer Received11/12/2014
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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