MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY 4085 SURGICAL TABLE

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 03/23/2015

Event Type  No Answer Provided  

Event Description

The user facility reported that during a patient procedure, the hand control to their 4085 surgical table displayed "error code 10".The user facility utilized the back-up hand control and the procedure was completed successfully.No report of injury or procedural delays or cancellations.

Manufacturer Narrative

A steris service technician inspected the table and found that the rubber pad to one of the floor lock cylinders was missing.With the rubber pad missing from the floor lock cylinder the foot was unable to make contact with the floor.The table operated properly when displaying the error code 10 message on the hand control as it detected a loss of pressure from the floor lock cylinder due to the floor lock foot not making contact with the floor.The 4085 operator manual states "10 alarm-floor locks not detected.Floor lock pressure switch failure".The technician repaired the table and returned it to service.No additional issues have been reported.The user facility properly utilized the back-up hand control as stated in the operator manual.The operator manual states (pp.4-7), "the steris 4085 general surgical table is equipped with an auxiliary control system.This system can be actuated at any time and allows table operation in the event of primary control malfunction." the rubber pad is likely missing due to hospital personnel moving the table over door jambs or uneven surfaces.The operator manual states (pp.1-4), "caution-possible equipment damage: when moving the table to or from point of use, roll it carefully at moderate speed and only over smooth floors.Avoid door and elevator jambs, and obstructions greater than ¼".".

• 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 Key: 4694945
• MDR Text Key: 5636152
• Report Number: 1043572-2015-00030
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2015
• 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 Received: 03/23/2015
• 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 Number: 1