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

Device Problems Detachment Of Device Component (1104); Positioning Problem (3009)

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

Event Date 03/10/2015

Event Type  No Answer Provided  

Event Description

The user facility reported during a patient procedure, their 4085 surgical table's slide was in the max position towards the head of the bed when the table's feet came off of the floor.Also the table was not able to reverse from trendelenburg position without adjusting the table slide into center position.No report of injury or procedural delay or cancellation.

Manufacturer Narrative

A steris field service technician arrived onsite, inspected the table, and found the table was operating properly.The technician confirmed that the patient was repositioned more toward one end of the surgical table.When the patient's weight shifted, the table's feet came off of the floor.The 4085 patient positioning instructions quick reference guide shows a suggested position for the same type of procedure in which the table is not in full slide to the head, but rather more to the center of the table.Also section 1, safety precautions, of the operator manual states, "with patient in normal or reverse orientation, table in trendelenburg and slide at head limit, center tabletop before attempting to raise table to level or move into reverse trendelenburg." therefore the table operated as designed and would not reverse trendelenburg before the table was repositioned to the center.Although the reported event was able to be duplicated, this issue is attributed to improper patient positioning.The distribution of patient weight was improper and therefore the tipping was not considered to be a malfunction of the table.Steris conducted in-service training with the user facility about proper positioning and operation of the 4085 surgical table.

• 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: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 4669644
• MDR Text Key: 5621906
• Report Number: 1043572-2015-00028
• 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
• Type of Report: Initial
• Report Date: 04/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/10/2015
• 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
• Patient Outcome(s): Other