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

Device Problem Fire (1245)

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

Event Date 11/21/2017

Event Type  malfunction  

Manufacturer Narrative

Contrary to the reported event, the power cord did not catch fire.The user facility stated they observed sparking and a small amount of smoke.No injury occurred as a result and the procedure was completed successfully without delay.The user facility stated that after re-positioning a patient during a procedure, user facility personnel noticed the power cord for the table was lightly sparking and smoking.User facility personnel unplugged the power cord from the wall, and the procedure was completed without issue.After completion of the procedure, the table was removed from service pending review from a steris service technician.A steris service technician arrived on-site and identified that the ac inlet, ac power cord, and table control and motor pump batteries were not operating properly.The technician found the user facility used a non-steris power cord with the table, which arced at the ac inlet on the table.The user facility also stated the batteries were not holding a charge, as a result they were using the table with the power cord plugged in.The steris technician concluded that the issues identified were a result of a failure to perform maintenance of the table and use of a non-steris power cord.The steris operator manual states on page 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 faithful performance of routine maintenance.Contact steris to schedule preventive maintenance.Repairs and adjustments to this equipment must be made only by fully qualified service personnel.Nonroutine maintenance performed by inexperienced, unqualified personnel or installation of unauthorized parts could cause personal injury, invalidate the warranty, or result in costly damage.Contact steris regarding service options." the 3085sp surgical table was installed at the user facility in 1998 and is not under steris contract for maintenance services.All maintenance is performed by the user facility.The steris technician replaced the ac inlet, ac power cord, table control battery and motor pump battery; tested the unit and confirmed it to be operating according to specification.The table was returned to service and no additional issues have been reported.

Event Description

The user facility reported their steris 3085sp surgical table's power cord caught fire during a patient procedure.

• 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: 7135195
• MDR Text Key: 95635273
• Report Number: 1043572-2017-00084
• 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: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• 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: 11/21/2017
• 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