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

Device Problem Loss of Power (1475)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/05/2021

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the 3085 sp surgical table.The technician found the power supply was not operational and batteries would not take a charge.As the power supply and batteries were not working, this resulted in the loss of power to the table.The 3085 sp surgical table has an indicator that appears on the hand control display screen that indicates how charged the batteries are.The technician inspected the hand control and confirmed the indicator was operating properly.The 3085 sp surgical table operator manual states (6-6), " motor and control batteries* will require recharging on a periodic basis depending on frequency of table usage.Low or discharged battery conditions are indicated by leds on the hand control as explained in the hand control diagnostic chart in section 7." the operator manual further states (4-3), "the table will continue to function normally for at least 24 hours after the battery down led (see section 1, definition of symbols) first illuminates.If the led illuminates during a procedure, complete the procedure and recharge the batteries at the end of the day.If the battery down led is flashing, immediately connect the ac power cord to the table base and plug into an appropriate ac receptacle (see figure 6-3)." the unit was installed in 2008 making it approximately 13 years old and is not under steris service agreement; the user facility is responsible for all maintenance activities.The technician replaced the power supply.The user facility elected to replace the batteries and returned the table to service.A steris account manager offered in-service on the proper use, operation, and maintenance of the 3085 sp surgical table, specifically monitoring the led display for low battery; steris is awaiting the user facility's response.A follow-up mdr will be submitted when additional information becomes available.

Event Description

The user facility reported that during a patient procedure their 3085 sp surgical table lost power.The patient was transferred to a different surgical table resulting in a procedure delay.The procedure was completed successfully.No report of injury.

Manufacturer Narrative

A steris account manager offered in-service training on the proper use, operation, and maintenance of the 3085 sp surgical table, specifically monitoring the led display for low battery; however, the user facility declined.No additional issues have been reported.

• Brand Name: 3085 SP SURGICAL TABLE
• Type of Device: SURGICAL TABLE
• Manufacturer (Section D): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery AL 36109
• MDR Report Key: 11787488
• MDR Text Key: 265146465
• Report Number: 1043572-2021-00033
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1