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

Device Problem Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/10/2020

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the 3085 sp surgical table and found that the power supply which charges the table's batteries required replacement.As the power supply was not working, the batteries lost their charge resulting in the loss of power to the table.The valve for the trendelenberg position was open due to the commanded movement when the batteries lost their charge resulting in the reported drift.The 3085 sp surgical table has an indicator that appears on the hand control display screen that indicates how charged the batteries are.The 3085 sp surgical table operator manual states (1-2), "note: battery-powered tables should be switched off after each procedure to prevent unnecessary battery discharge.If low battery condition is indicated by the hand control led.The table will continue to function normally for at least 24 hours after the battery down led (definition of symbols) first illuminates.If the led illuminates during a procedure, complete the procedure and recharge the batteries at the end of the day.If the battery down led is flashing, immediately connect the ac power cord to the table base and plug into an appropriate ac receptacle." additionally, the user facility should have utilized 3085 sp surgical table auxilliary override system in the event of a power loss.The operator manual states (5-1), " the amsco® 3085 sp¿ convertable bariatric surgical 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 unit was installed in 2002 making it approximately 18 years old and is not under steris service agreement; the user facility is responsible for all maintenance activities.The technician made the necessary repairs to the table, tested the table, confirmed it to be operating according to specification, and returned it to service.A steris account manager offered in-service on the proper use, operation, and maintenance of the 3085 sp surgical table, specifically monitoring the led display for low battery and operation of the manual foot pump; steris is awaiting the user facility's response.

Event Description

The user facility reported that during a patient procedure their 3085 sp surgical table was commanded into trendelenberg position and when the trend command was released on the hand control the table continued to drift slowly down.Once the movement stopped, facility personnel identified that the table did not have any power and would not respond to hand control commands resulting in a procedure delay.The procedure was completed successfully on the table as positioned; no report of injury.

Manufacturer Narrative

A steris account manager offered in-service on the proper use, operation, and maintenance of the 3085 sp surgical table, specifically monitoring the led display for low battery and operation of the manual foot pump; however, the user facility declined.No additional issues have been reported.

• Brand Name: 3085 SP SURGICAL TABLE
• Type of Device: SURGICAL TABLE
• Manufacturer (Section D): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery, al
• MDR Report Key: 10257956
• MDR Text Key: 208975080
• Report Number: 1043572-2020-00030
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2020
• 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: 06/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1