MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY 5085SRT SURGICAL TABLE

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

Patient Problem Fall (1848)

Event Date 05/22/2014

Event Type  No Answer Provided  

Event Description

The user facility reported after a completed procedure with the patient still on the surgical table, the patient slid off of the table and onto the floor.No injuries or procedural delays/cancellations were reported.

Manufacturer Narrative

Following the reported event, the facility contacted steris service as they requested the surgical table be inspected for proper operation.A steris service technician arrived at the facility, inspected the table and found the equipment operating to specification.No faults with the table were identified and the table was turned back to the facility for use.The technician was informed by facility staff that the event occurred as the staff was moving the patient off the table to a stretcher for transport to another location.The steris account manager contacted the facility to provide additional in-service training on the proper use and operation of the surgical table however, the user facility was unresponsive.The table was installed in december of 2012 and is currently under steris extended warranty.No further issues have been reported.

• Brand Name: 5085SRT 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: 3884611
• MDR Text Key: 15107352
• Report Number: 1043572-2014-00054
• 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: 06/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 05/22/2014
• Initial Date FDA Received: 06/19/2014
• 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