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

Device Problem Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/17/2017

Event Type  malfunction  

Manufacturer Narrative

No procedure delays or cancellations were reported.User facility personnel commanded the table floor locks to unlock in order to reposition the table in the room.Following the unlocking of the floor locks with the patient present the table began to tilt.A steris service technician arrived onsite to inspect the surgical table.During the technicians inspection, he found the surgical table to be operating properly with no issues with the function or operation.The technician tested the table and returned it to service.No additional issues have been reported.User facility personnel should not have unlocked the table floor locks with a patient present as stated in the operator manual.The operator manual states (pp.1-1), "do not place patient on the table unless floor locks are engaged.Do not disengage floor locks when patient is on table." a steris account manager performed in-service training on the proper use and operation of the 4085 surgical table.

Event Description

The user facility reported that their surgical table tilted during a patient procedure.No report of injury.

• Brand Name: 4085 SURGICAL TABLE
• Type of Device: 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: lyndsey snyder ; 5960 heisley road; mentor, OH 44060 ; 4403927386
• MDR Report Key: 6785407
• MDR Text Key: 82599934
• Report Number: 1043572-2017-00056
• 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: 08/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2017
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/17/2017
• 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