MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY 4095 SURGICAL TABLE

Model Number	4095 Surigical Table
Medical Device Problem Code	Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure their 4095 surgical table lost power.The table was previously placed in the desired position prior to losing power and the patient procedure was completed successfully.No report of injury.
Additional Manufacturer Narrative
A steris service technician inspected the table and found the master control table assembly had come off the mounting brackets subsequently causing the master control table assembly to sustain damage when the tabletop lowered in height.The table's column shrouds may have been impacted by other equipment subsequently causing the mounting brackets to become misaligned.When the table height was adjusted, the column shrouds contacted the mounting brackets causing the master control table assembly to sustain damage and the table to lose power.The operator manual states (section 1), "do not store items on table base.Doing so may result in equipment damage or inadvertent tabletop movement placing the patient and/or user at risk of injury." the steris service technician repaired the 4095 surgical table and confirmed it to be operating properly.The technician discussed his inspection results with user facility personnel and returned the table to service.No additional issues have been reported.

• Brand Name: 4095 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 ; 4403927453
• MDR Report Key: 15633581
• Report Number: 1043572-2022-00066
• Device Sequence Number: 15455710
• Product Code: FQO
• UDI-Device Identifier: 00724995195243
• UDI-Public: 00724995195243
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/19/2022

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
• Operator of Device: Health Professional
• Device Model Number: 4095 Surigical Table
• Device Catalogue Number: ST013921022
• 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: 09/19/2022
• Initial Report FDA Received Date: 10/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2022
• 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