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

Device Problem Unintended System Motion (1430)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/24/2020

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite following the reported event to inspect the 3085 sp surgical table.The technician observed that the table's column shroud covers were separated, and the auxiliary override control switches were damaged.The technician spoke with facility personnel who stated that they had been storing items on the base of the table.The 3085 sp surgical table operator manual states (pg.1-3): "caution - personal injury and/or equipment damage hazard: storing items on the table base may result in equipment damage causing inadvertent tabletop movement placing patient and/or user at risk of personal injury.Do not use table base for storage." the technician made the necessary repairs and replacements, tested the functionality of the table, and found it to be operating according to specifications.The table was returned to service.The account manager counseled user facility on the importance of not storing items on the base of the table in accordance with the operator manual.No additional issues have been reported.

Event Description

The user facility reported that during a patient procedure, their 3085 sp surgical table began to articulate without being commanded to do so.The user facility was able to transfer the patient to another table and the procedure was completed successfully.No report of injury.

• Brand Name: 3085 SP SURGICAL TABLE
• Type of Device: SURGICAL TABLE
• Manufacturer (Section D): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery, al
• Manufacturer (Section G): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery, al
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, oh ; 3927453
• MDR Report Key: 9990976
• MDR Text Key: 209025107
• Report Number: 1043572-2020-00022
• 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: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2020
• 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: 03/24/2020
• 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