MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY 5085 SURGICAL TABLE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 04/03/2019

Event Type  malfunction  

Manufacturer Narrative

The user facility requested the testing to determine if the table caused a patient to slip off the table.No report of injury.A procedure delay was reported.A steris service technician arrived onsite to inspect the 5085 surgical table and found the table to be operating properly.The table performed as commanded; no issue with the function or operation of the table was identified and the table was returned to service.The user facility reported that during the time of the reported event, the table was tilted head down and left with a safety strap across the patient's lap when the patient slipped of the table.The reported event is attributed to user error as user facility personnel should have ensured the patient was properly secured.The 5085 surgical table operator manual states (1-2), "warning - personal injury hazard: failure to keep the patient properly secured with the patient safety straps at all times could result in death or serious injury." the operator manual further states (1-2), "warning - personal injury hazard: unanticipated table movement could cause patient injury.Patient must be secured to the table in accordance with recommended positioning practices." a steris account manager counseled user facility personnel on ensuring the patient was properly secured.No additional issues have been reported.

Event Description

The user facility contacted steris and requested functional testing of their 5085 surgical table.The request was part of the hospital's investigation into a patient slipping off the surgical table.

• Brand Name: 5085 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: 8578472
• MDR Text Key: 145787321
• Report Number: 1043572-2019-00029
• 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: 05/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 04/03/2019
• Initial Date FDA Received: 05/03/2019
• 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