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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fall (1848)

Event Date 07/15/2020

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the 3085 sp surgical table.The technician tested the function and articulations of the table and found the table to be operating properly; no issues were identified, and the table was returned to service.During the time of the reported event, the table was tilted and in trendelenburg position with a safety strap on the patient's legs.While onsite, the technician spoke with user facility personnel who indicated that the safety strap should have been properly secured during the time of the reported event.The reported event is attributed to user error as user facility personnel should have ensured the patient was properly secured.The 3085 sp surgical table operator manual states (1-2), "patient must be secured to the table in accordance with recommended positioning practices." a steris account manager performed in-service training on the proper use and operation of the table, specifically ensuring the patient is properly secured.No additional issues have been reported.

Event Description

The user facility reported that during a procedure the patient slipped off of the 3085 sp surgical table and fell to the floor.The user facility picked up the patient and placed the patient back onto the table.The procedure was completed successfully.No injuries were associated with the reported event.

• 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: 10372427
• MDR Text Key: 208958948
• Report Number: 1043572-2020-00033
• 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: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2020
• 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