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

Device Problems Device Emits Odor (1425); Smoking (1585)

Patient Problem No Code Available (3191)

Event Date 05/31/2018

Event Type  malfunction  

Manufacturer Narrative

The table was immediately unplugged and removed from service following the reported event.The 4085 surgical table is not under steris service agreement for maintenance activities.All maintenance activities are performed by a third-party.A steris service technician arrived onsite to inspect the surgical table and found that one of the screws on the base cover was missing a nylon washer.The technician removed the base cover and observed evidence of smoke damage on the power supply connector and evidence of fluid intrusion on the power supply.Based on the technician's inspection, it appears that the fluid intrusion on the power supply occurred during a prior procedure.The technician stated that the absence of screw's nylon washer on the base cover allowed fluid intrusion into the base of the table.The fluid intrusion caused the electrical components to short subsequently causing the reported event to occur.The technician replaced the power supply, ensured that the table's base was properly sealed, tested the table, and returned it to service.The technician counseled user facility personnel on the proper use and operation of the table, specifically, ensuring all screws and nylon washers are properly secured following any maintenance activities.No additional issues have been reported.

Event Description

The user facility reported that prior to the start of a patient procedure a burning odor and smoke were emitting from the base of the 4085 surgical table.The patient was immediately transferred to a different or room and the procedure was completed successfully.There were no injuries to the patient or staff associated with the reported event.

• Brand Name: 4085 SURGICAL TABLE
• Type of Device: 4085 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: 7652407
• MDR Text Key: 113181252
• Report Number: 1043572-2018-00053
• 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: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• 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: 05/31/2018
• 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