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

Device Problem Sparking (2595)

Patient Problem Electric Shock (2554)

Event Date 07/19/2019

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the table and found the retaining tab of the fuse holder within the ac plate assembly to be broken off.The damaged ac plate caused an inadequate electrical connection resulting in the reported event.The table was installed in 1998 making it approximately 21 years old and is not under steris service agreement.The user facility is responsible for all maintenance activities.The 3085sp surgical table operator manual states (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 regular performance of routine maintenance.Contact steris to schedule preventive maintenance." the reported event is attributed to improper maintenance activities.The user facility did not perform proper preventive maintenance activities, specifically the biannual inspection of the ac plate, as outlined in the 3085sp maintenance manual.The 3085sp surgical table preventive maintenance check list states, "4.3 check power cord and ac plate for damage.Replace as needed.2 x per year." the technician replaced the ac plate, tested the table, confirmed it to be operating according to specification and returned it to service.The technician counseled facility personnel on the proper use and operation of the 3085sp surgical table, specifically performing proper preventive maintenance.No additional issues have been reported.

Event Description

The user facility reported that while an employee was attempting to plug a power cord into their 3085sp surgical table a spark emitted and contacted their arm.No medical treatment was sought or administered.No patient was present at the time the reported event.

• 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: 8907198
• MDR Text Key: 208019556
• Report Number: 1043572-2019-00070
• 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: 08/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2019
• 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: 07/22/2019
• 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