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

Device Problems Self-Activation or Keying (1557); Unintended Movement (3026)

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

Event Date 05/30/2018

Event Type  malfunction  

Manufacturer Narrative

Based on the event, the patient was not properly secured to the surgical table subsequently causing the patient to slide when the table's unexpected movement occurred.No patient restraints were used to keep the patient from sliding.The operator manual states (pp.4-8), "warning - personal injury hazard: unanticipated table movement could cause patient injury.Patient must be secured to the table in accordance with recommended positioning practices".Following the event, facility personnel tested the function and operation of the table and were unable to duplicate the un-commanded table movement.A steris service technician arrived onsite to inspect the surgical table and found the table to be operating properly.The technician was unable to duplicate the reported movement.The technician removed the table's column shroud to inspect all wiring and found the table to be operating according to specification; no repairs were required.Additionally, the technician inspected the hand control and auxiliary hand control and found both to be operating according to specification.Based on the description of the event, the reported event appears to be attributed to a powered movement via inadvertent hand control activation.No additional issues have been reported.

Event Description

The user facility reported that during the conclusion of a patient procedure the 4085 general surgical table began to move into trendelenburg positon without being commanded to do so causing the patient to begin to slide off the table.Facility personnel stabilized the patient and utilized the hand control to bring the table back into the desired position.Once the patient was stabilized they were transferred to another table and the procedure was completed successfully.No injury to the patient was reported.

• Brand Name: 4085 SURGICAL TABLE
• Type of Device: 4085 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: 7650954
• MDR Text Key: 112898779
• Report Number: 1043572-2018-00052
• Device Sequence Number: 0
• Product Code: FQO
• Reporter Country Code: CA
• 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: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/30/2018
• Initial Date FDA Received: 06/29/2018
• 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