MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY 3085SP SURGICAL TABLE

Device Problem Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/06/2014

Event Type  No Answer Provided  

Event Description

The user facility reported their surgical table continued to tilt after the tilt button on the table was released.No injuries or procedural delays or cancellations were reported.

Manufacturer Narrative

The table laterally tilted left and continued after release of the button.The table is serviced by device technologies (b)(4) and was last serviced on (b)(4) 2014 and has been in use for over 10 years.The investigation of this event is currently in process.A follow-up report will be submitted when additional information becomes available.

Manufacturer Narrative

A service technician inspected the unit and identified that the table did not operate properly when running solely on battery power; no issues were noted when the table was plugged into a main power source.The technician replaced the table motor and control batteries.The table control board contains circuitry that will cause the table to shut down if the battery voltage is too low for correct circuit operation.Investigation by steris engineering determined the table's control board should be replaced as the control board may not have properly detected the battery voltage.The table control board was replaced and no additional issues have been reported.

• 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 Key: 4227733
• MDR Text Key: 4996505
• Report Number: 1043572-2014-00115
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2014
• 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 Received: 10/09/2014
• 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 Number: 1