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

Model Number	4095 Surigical Table
Medical Device Problem Code	Device Tipped Over (2589)
Health Effect - Clinical Code	Fall (1848)
Date of Event	04/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the 4095 surgical table and found the unit to be operating according to specification.No issues with the function or operation of the table were found and the unit was returned to service.While onsite, the technician spoke with facility personnel who stated at the time of the reported event the patient was placed on the table while the tabletop was already fully extended toward the head end.The 4095 surgical table operator manual states (4), "warning tipping hazard center tabletop over column before transferring patient on or off of surgical table." a patient should not be placed on the table while it is fully extended as the tabletop should always be centered to ensure stability.As the patient's weight was not evenly distributed over the column on the table, this allowed the reported event to occur.The reported event is attributed to user error as facility personnel should have centered the tabletop over the column prior to positioning the patient.A steris account manager performed in-service training with user facility personnel on the proper use and operation of the 4095 surgical table, specifically to center the tabletop over the table column prior to transferring the patient.No additional issues have been reported.
Event or Problem Description
The user facility reported that prior to the start of the procedure a patient transferred themselves to the table causing their 4095 surgical table to tip downward hitting the floor.The patient fell from the table to the floor resulting in back pain.The procedure was completed successfully.

• 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
• MDR Report Key: 16993949
• Report Number: 1043572-2023-00107
• Device Sequence Number: 6984477
• Product Code: FQO
• UDI-Device Identifier: 00724995195236
• UDI-Public: 00724995195236
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 05/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 4095 Surigical Table
• Device Catalogue Number: ST013911002
• 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: 04/25/2023
• Initial Report FDA Received Date: 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2023
• 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