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

Device Problem Loss of Power (1475)

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

Event Date 05/12/2014

Event Type  No Answer Provided  

Event Description

The user facility reported that their 3085 surgical table was losing power during a patient procedure.User facility personnel were able to use the auxiliary switches to complete the procedure successfully.No injuries or procedural delays/cancellations were reported.

Manufacturer Narrative

A steris service technician inspected the table and found the hand control was indicating low battery power.He noted that one of the leads on the control batteries had some corrosion which likely caused the reported loss or intermittent power issues.The technician replaced the control batteries and as a precautionary measure replaced the power supply.The technician tested the table and returned it to service; no additional issues have been reported.The table is not under steris service contract and is serviced and maintained by the user facility.

• 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: 3848961
• MDR Text Key: 4687124
• Report Number: 1043572-2014-00053
• 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: 06/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2014
• 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