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 10/09/2019

Event Type  malfunction  

Manufacturer Narrative

User facility personnel failed to immediately disconnect the power cord from the table when the "voltage peak" message appeared as instructed in the 4085 surgical table operator manual.The patient should have been moved to another table, and the table should have been removed from service until the table's power supply was replaced.The operator manual (pg.6-4) states: "fault display: voltage peak.Fault action: immediately disconnect power cord; replace power supply." a steris service technician replaced the table's power supply, tested the table and hand control, found them to be operating according to specification, and returned them to service.While onsite, the technician counseled user facility personnel on the proper use and function of the 4085 surgical table specifically, the importance of immediately disconnecting the power cord from the table in the event of a voltage peak message and removing it from service until the table's power supply can be replaced, as well as how to utilize the table's manual override controls so they could manually move the table in the event of power loss.No additional issues have been reported.

Event Description

The user facility reported that prior to the start of a procedure, with a patient on the table, operating room personnel were attempting to adjust the table to the desired position when a "voltage peak" message appeared on the display screen of their 4085 surgical table's hand control.After approximately five minutes of attempting to troubleshoot, operating room personnel elected to begin the procedure with the table at its current position.The procedure was completed successfully.No report of injury.

• 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: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 9299207
• MDR Text Key: 209004382
• Report Number: 1043572-2019-00095
• 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: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2019
• 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: 10/09/2019
• 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