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

Device Problem Failure to Read Input Signal (1581)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/03/2018

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite following the reported event to inspect the 3085sp surgical table and found the root cause of the event to be attributed to the floor lock mechanism.The technician noticed that the limit switch on the floor lock mechanism was not being fully activated.This limit switch sends a signal to the hand control, which allows the hand control to detect that the floor locks to the table are engaged.If the hand control cannot detect that the floor locks are engaged, the table will not respond to any hand control inputs.The technician adjusted the floor lock mechanism and returned the table to service.The user facility personnel did not utilize the auxiliary override systems as described in the operator manual.The 3085sp operator manual states (pp.5-1), "table is equipped with auxiliary override systems that can be actuated at any time and that will allow table operation in the event of primary control malfunction." the user facility was counseled on the proper operation of the table including the use of the auxiliary override system control switches.No additional issues have been reported.

Event Description

The user facility reported that the 3085sp surgical table would not respond to commands during a patient procedure.No report of injury or procedure delay.The procedure was completed successfully.

• 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: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 8002579
• MDR Text Key: 125648391
• Report Number: 1043572-2018-00083
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 10/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2018
• 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: 10/03/2018
• 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