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

Device Problems Thermal Decomposition of Device (1071); Smoking (1585)

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

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite following the reported event and the technician removed the base covers and observed fluid around the table's power supply.Additionally, the technician noted that the upper column covers showed evidence of open gaps that would have allowed fluid intrusion.The 4085 surgical table is designed to meet ipx4 fluid ingress standards, and the normal fit of the covers, along with the rtv sealant that is applied, will prevent fluid intrusion.The technician replaced the power supply, properly sealed the table, and confirmed the table was operating according to specifications.This event is likely attributed to items being stored on the base of the table.Storing items on the base of the table could cause gaps in the column covers allowing fluid intrusion and the reported event to occur.The 4085 surgical table operator manual states (pg.14), "warning personal injury and/or equipment damage hazard: do not store items on table base.Doing so may result in equipment damage or inadvertent tabletop movement placing the patient and/or user at risk of injury." additionally, the table has a warning label that states, "warning-do not store items on base- personal injury hazard/equipment damage".No additional issues have been reported.

Event Description

The user facility reported that the 4085 surgical table was emitting smoke and a burning odor from the base of the table at the end of a patient procedure.

• 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: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 7606274
• MDR Text Key: 112179626
• Report Number: 1043572-2018-00047
• 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: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/16/2018
• 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