MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY 5085 STR 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 03/30/2018

Event Type  malfunction  

Manufacturer Narrative

The table was installed at the customer's location in 2007 and is not under steris service contract agreement for maintenance activities.All preventive maintenance is performed by the user facility's biomed department.A steris service technician arrived onsite to inspect the surgical table and found that the locking mechanism that secures the headrest to the table was not operating properly.The technician identified the mechanical stop, a component of the headrest, was not holding the locked position allowing the headrest to lower in height.The 5085 surgical table operator manual instructs the user to verify the correct operation of the headrest prior to use of the 5085 srt table (pg.2-1), "table preparation: while holding head section securely in one hand, pull blue release handle (spring loaded) located under head section center rail and tilt head section to desired angle (level in this case).Release handle to lock head section at desired angle.Move headrest slightly until headrest is locked in position." following the event, the user facility purchased a replacement surgical table and headrest assembly.The table was installed the week of april 23, 2018.No additional issues have been reported.

Event Description

The user facility reported that during a patient procedure the 5085 str surgical table's headrest lowered in height.No report of injury, procedure delay or cancellation.

• Brand Name: 5085 STR 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: 7470545
• MDR Text Key: 107326592
• Report Number: 1043572-2018-00035
• 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: 04/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/30/2018
• Initial Date FDA Received: 04/27/2018
• 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