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

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

Patient Problem Fall (1848)

Event Date 01/15/2018

Event Type  malfunction  

Manufacturer Narrative

During the time of the reported event, the user commanded the table to tilt to the left when the patient slipped off the table, resulting in a procedure delay.The patient reported a sore neck and shoulder following the procedure and was prescribed muscle relaxers.A steris service technician arrived onsite following the reported event.The technician confirmed the unit to be operating according to specifications and returned the unit to service.The technician stated the reported event can be attributed to improper use of the unit.The patient was not properly secured to the table.The 5085 surgical table operator manual states (p.1-2), "failure to keep the patient properly secured with the patient safety straps at all times could result in death or serious injury.Unanticipated table movement could cause patient injury.Patient must be secured to the table in accordance with recommended positioning practices." the account manager offered in service training, but the user facility declined.No additional issues have been reported.

Event Description

The user facility reported that during a procedure, a patient slid off a 5085 surgical table onto the floor.

• 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: 7272016
• MDR Text Key: 100427894
• Report Number: 1043572-2018-00013
• 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: 02/14/2018

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/15/2018
• Initial Date FDA Received: 02/14/2018
• 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