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

Device Problem Smoking (1585)

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

Event Date 04/26/2019

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite following the reported event to inspect the 3085 surgical table.The technician found a broken ac plate and evidence of charring.Additionally, medical tape had been placed by user facility personnel on and within the ac plate and plug.The root cause of the reported event is improper maintenance as user facility personnel should not have utilized the table with a damaged ac plate.The table was installed in 2003 making it approximately 16 years old and is not under steris service agreement.The user facility is responsible for all maintenance activities.The 3085 sp surgical table operator manual states (1-2), "warning - personal injury and/or equipment damage hazard: safe and reliable operation of this equipment requires regularly scheduled preventive maintenance, in addition to the regular performance of routine maintenance.Contact steris to schedule preventive maintenance." the technician replaced the ac plate, tested the unit, confirmed it to be operating according to specifications, and returned it to service.The technician counseled user facility personnel on the proper use and operation of the 3085 surgical table, specifically performing proper preventive maintenance.No additional issues have been reported.

Event Description

The user facility reported that during a patient procedure their 3085 surgical table was smoking near the ac plug.The procedure was completed successfully.There was no report of injury or inhalation/irritation.A procedure delay was reported as the table was removed from service and a new table was brought in to be utilized.

• Brand Name: 3085 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: 8634225
• MDR Text Key: 145924087
• Report Number: 1043572-2019-00038
• 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: 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 04/26/2019
• Initial Date FDA Received: 05/22/2019
• 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