MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY 4085 SURGICAL TABLE

Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the unit and stated he was unable to recreate the reported issue and did not detect any functional issues with the surgical table.The customer indicated that they have been trained on properly transferring patients from the table.This is considered an isolated event.The 4085 general surgical table operator manual states, "warning - tipping hazard: do not place patient on this surgical table unless floor locks are engaged.Center tabletop over column before transferring patient on or off surgical table." the steris service technician inspected the table, confirmed it to be operating according to specification, and returned the unit to service.As this is an isolated event and it was determined that the table was operating according to specification, the reported event is likely attributed to the floor locks not being engaged or the tabletop of the unit not being centered.No additional issues have been reported.
Event or Problem Description
The user facility reported that following a procedure their 4085 surgical table began to tip over while moving a patient off the table to a stretcher.No report of injury.

• Brand Name: 4085 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: 19558797
• Report Number: 1043572-2024-00040
• Device Sequence Number: 4851085
• Product Code: FQO
• UDI-Device Identifier: 00724995154783
• UDI-Public: 00724995154783
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/18/2024

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
• 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: 05/21/2024
• Initial Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2019
• 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