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

Device Problems Unintended Head Motion (1284); Device Slipped (1584)

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

Event Date 07/08/2014

Event Type  No Answer Provided  

Event Description

(b)(4).

Manufacturer Narrative

The user facility reported that during a patient procedure hospital personnel unlocked the floor locks to rotate the table 90 degrees and the surgical table started to tip head first.Hospital personnel were able to stabilize the table.The procedure was completed successfully.No injuries or procedural delays or cancellations were reported.The operator manual states (pp.1-1), "do not disengage floor locks when patient is on table." steris discussed the proper operating procedures for the 4085 table.The table was installed on 6/23/2014 and is under steris warranty.The user facility did not contact steris service at the time of the event and consequently steris did not have the opportunity to evaluate the surgical table.A steris service technician was onsite after the reported event for unrelated maintenance activities.At this time the table was found to be operating properly.No additional issues have been reported.(b)(4).

• 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: 4200433
• MDR Text Key: 18931994
• Report Number: 1043572-2014-00106
• 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: 10/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2014
• 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: 09/25/2014
• 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