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

Device Problem Unintended Head Motion (1284)

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

Event Date 10/28/2014

Event Type  No Answer Provided  

Event Description

The user facility reported during a patient procedure, their 3085 surgical table tipped and almost allowed for a patient to fall from the table.The tipping motion was noted by or staff who prevented the table from tipping further.The procedure was successfully completed without further incident.

Manufacturer Narrative

A steris field service technician arrived onsite, inspected the table, and was not able to identify any table malfunction.The technician was informed the table was positioned in the reverse orientation at the time of the event.In the reverse orientation, the patient's mass is over the shorter section of the supporting table base.During the procedure, the hospital staff disengaged the table floor locks.The 3085 surgical table operator manual states on page 1-1, "warning: tipping hazard: do not place patient on table unless floor locks are engaged," and "do not release floor locks while patient is on table".This tipping warning is reiterated in section 2.2 and on the column shroud's warning label.The technician confirmed the table to be operating according to specification.The technician provided the hospital staff and nurse manager a copy of the operator manual to review proper patient positioning, tipping hazards, and weight limitations.

• Brand Name: 3085 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: 4266712
• MDR Text Key: 5225201
• Report Number: 1043572-2014-00123
• 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: 11/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2014
• 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: 10/28/2014
• 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