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 10/18/2018

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite and spoke with user facility personnel regarding the reported event.The user facility informed the technician that the reported flame was observed when an employee entered the operating room.No patient was present during the reported event.The flame had "fizzled out" and the employee unplugged the cord from the table and unplugged the table from the or wall outlet before the fire department arrived.The technician inspected the surgical table and found that the table's ac power cord and plate inlet were burnt and melted.While onsite the technician replaced that ac power cord and plate inlet, tested the table, and returned it to service.Due to the observed rusting and dried chemical residue at the bottom of the table in close proximity to the power inlet, the root cause of the reported event can be attributed to exposure to liquid from cleaning.The 3085sp surgical table's operator manual (1-3) states: "caution: possible equipment damage: do not spray cleaning fluid into electric receptacles and avoid spraying directly onto override switches or into clearance space above column.Spray or drippage may settle onto electric circuits inside table causing corrosion and loss of function." the 3085sp surgical table was installed in september 2000 making this table approximately 18 years old and is not under steris service agreement for maintenance activities.A steris account manager will offer in-service training on the proper use and operation of the 3085sp surgical table specifically, proper cleaning techniques.

Event Description

The user facility reported that flames were observed on the cord and inlet of their 3085sp surgical table.The facility was evacuated, and the fire department was called.No injury was reported.

Manufacturer Narrative

A steris account manager offered in-service training on the proper use and operation of the 3085 surgical table specifically, proper cleaning techniques; however, the user facility declined.No additional issues have been reported.

• 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: 8080347
• MDR Text Key: 127593124
• Report Number: 1043572-2018-00095
• 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,Followup
• Report Date: 11/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2018
• 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
• Date Manufacturer Received: 10/18/2018
• 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