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

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 12/12/2014

Event Type  No Answer Provided  

Event Description

The user facility reported that during a patient procedure the primary hand control was displaying an error message (lock again, then slide).The user facility also reported that a wrench icon was next to the maintenance display.During the reported event, user facility personnel contacted their biomedical department who then contacted steris technical support.Steris walked the biomed through the proper procedure for utilizing the back-up hand control and the procedure was completed successfully.No injuries were reported however, a procedural delay was reported.

Manufacturer Narrative

A steris service technician arrived onsite and found the surgical table subject of the reported event to be located in the hallway.The table was unplugged and the main power switch was in the off position.The technician also indicated that the battery level was low.The technician articulated the table on battery and main power and found the table to be operating properly.The reported event was unable to be duplicated.The technician further locked and unlocked the table via the primary hand control a dozen times and no issues were noted.The technician inspected the primary hand control and no error messages were displayed.The technician plugged in the table to ensure proper full charge was obtained and returned the table to service.No additional issues have been reported.User facility personnel were advised of the importance of proper charging of the table however they declined additional in-service training to be performed.

• 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: 4404298
• MDR Text Key: 18068615
• Report Number: 1043572-2015-00003
• 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: 01/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2014
• 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