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

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Electric Shock (2554)

Event Date 08/20/2020

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the surgical table and noted that the ac plate was not properly mounted to the front of the table base resulting in the reported event.The table was installed in 2002 making it approximately 18 years old.The table is not under steris service agreement; the user facility's biomed department is responsible for all maintenance activities.The 3085 surgical table operator manual states (6-2), "table 6-1.Preventive maintenance schedule for the 3085 surgical table: 5.1 check all circuit board connectors and cable plugs are tight.Minimum frequency: 6x per year." the technician replaced the ac plate assembly and power cord, tested the unit, confirmed it to be operating according to specifications, and returned it to service.A steris account manager offered in-service training on proper preventive maintenance on the 3085 surgical table to the user facility; the training is scheduled for 9/29/2020.No additional issues have been reported.

Event Description

The user facility reported that a staff member was shocked while plugging in their 3085 surgical table prior to a procedure.No patient was present at the time, reported event occurred during procedure setup.No report of injury.

Manufacturer Narrative

A steris account manager performed in-service training on the proper use and operation of the 3085 surgical table, specifically proper preventive maintenance activities.No additional issues have been reported.

• Brand Name: 3085 SURGICAL TABLE
• Type of Device: SURGICAL TABLE
• Manufacturer (Section D): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery AL 36109
• MDR Report Key: 10543615
• MDR Text Key: 208759277
• Report Number: 1043572-2020-00040
• 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: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• 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: 08/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1