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

Device Problem Fire (1245)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/16/2022

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite following the reported event to inspect the 3085 sp surgical table and found that the ac power cord's insulation was damaged.As the ac power cord's insulation was damaged this allowed for the internal conducting wires to become exposed causing an electrical short and the reported event to occur.The user facility's third-party service provider replaced the power cord prior to the steris technician arriving onsite.The technician tested the table, confirmed it to be operating according to specifications, and returned it to service.A 2-year complaint review indicates this to be an isolated event.No additional issues have been reported.

Event Description

The user facility reported that their ac power cord to their 3085 sp surgical table caught fire.A patient was not on the table during the time of the reported event.No report of injury.

• Brand Name: 3085 SP 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: 13826234
• MDR Text Key: 287519394
• Report Number: 1043572-2022-00020
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 03/18/2022

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: 02/17/2022
• Initial Date FDA Received: 03/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2014
• 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