MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY 3080 SP SURGICAL TABLE

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

Patient Problem Fall (1848)

Event Date 11/07/2019

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the 3080 sp surgical table.The technician tested the function and articulations of the table and could not duplicate the reported event; the table's tilt mechanism was found to be operating properly.No repairs were required in association with the reported event.During the time of the reported event, the table was positioned slightly head down with a safety strap across the patient's lap.The user then commanded the table to tilt to the left when the patient slipped off of the table resulting in the reported event.The reported event is attributed to user error as user facility personnel should have ensured the patient was properly secured.The 3080 sp surgical table operator manual states (1-2), "warning - personal injury hazard: unanticipated table movement could cause patient injury.Patient must be secured to the table in accordance with recommended positioning practices." while onsite, the technician counseled facility personnel on the proper use and operation of the surgical 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 3080 sp surgical table and fell to the floor.The patient was taken for x-rays; no injuries were associated with the reported event.The procedure was completed successfully.

• Brand Name: 3080 SP SURGICAL TABLE
• Type of Device: 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: 9418135
• MDR Text Key: 208325888
• Report Number: 1043572-2019-00101
• 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: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• 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: 11/07/2019
• 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