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

Model Number	3085-R SURGICAL TABLE
Medical Device Problem Code	Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Following the reported event, the steris service technician inspected the table and found the batteries to have low charge.Additionally, the power supply and plate fuses were found to not be operating properly causing the table to lose power during the procedure.The 3085-r surgical table subject to the reported event is not under steris service agreement and is serviced and maintained by the user facility.The 3085-r remanufactured surgical table manual (pg.4 & 74) states "a thorough preventive maintenance program is essential for safe and proper unit operation.This manual contains basic maintenance schedules and procedures which should be followed for satisfactory equipment performance.Comprehensive instructions for monthly, quarterly and semi-annual preventive maintenance can be found in the maintenance manual (available from steris)." the technician replaced both batteries, power supply, and 4 of the faulty plate fuses.The table functionality was tested before returning to service.A steris account manager offered in service training on proper preventive maintenance activities; however, the user facility declined.No additional issues have been reported.
Event or Problem Description
The user facility reported that during a patient procedure, their 3085-r surgical table lost power.The procedure was completed successfully.No report of injury.

• Brand Name: 3085-R SURGICAL TABLE
• Common Device Name: 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
• MDR Report Key: 17137056
• Report Number: 1043572-2023-00117
• Device Sequence Number: 4058968
• Product Code: FQO
• UDI-Device Identifier: 00724995155025
• UDI-Public: 00724995155025
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2023

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
• Operator of Device: Health Professional
• Device Model Number: 3085-R SURGICAL TABLE
• Device Catalogue Number: RC4
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2023
• Supplement Date Received by Manufacturer: 05/19/2023
• Initial Report FDA Received Date: 06/15/2023
• Supplement Report FDA Received Date: 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown