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

Device Problems Device Emits Odor (1425); Overheating of Device (1437)

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

Event Date 01/09/2015

Event Type  No Answer Provided  

Event Description

The user facility reported that during a patient procedure, their 3085 surgical table overheated and arced from the ac power cord.A burning smell was reported and the patient was removed from the table and transferred to another table causing a procedural delay.The table was unplugged and removed from service.No injuries or cancellations were reported.No evacuations were required.No report of smoke or fire.

Manufacturer Narrative

A steris field service technician arrived onsite, inspected the table, and identified evidence of electrical arcing on the ac power cord and one of the ac inlet contacts.There was build-up on the electrical terminals and black discoloration.No external damage was visible on the power cord.The technician identified the cord subject of the reported event as a non-oem power cord; not approved as the original equipment manufacturer or an appropriate substitute by steris.Approved replacements for oem power cord types are outlined on page 55, table 8-1 in the operator manual.It is likely the power cord did not make proper contact with the inlet allowing for the arcing.When an arc occurs, heat is generated and could create the reported burning smell.The technician replaced the ac power cord with an oem power cord provided by the customer and the ac inlet assembly.He tested the unit and confirmed it to be operating according to specification before returning it to service.

• 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: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 4495048
• MDR Text Key: 5564965
• Report Number: 1043572-2015-00014
• 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
• Type of Report: Initial
• Report Date: 02/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/10/2015
• 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