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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/20/2018

Event Type  malfunction  

Manufacturer Narrative

User facility personnel rolled the patient onto their side to place a transfer board underneath the patient.This sequence caused an uneven distribution of patient and table weight resulting in the reported event.The table operator manual states (p.6), "warning-tipping hazard: do not place patient on the table unless floor locks are engaged.Do not release floor locks while patient is on table." a device technologies (b)(4) technician arrived onsite to inspect the surgical table and found it to be operating properly.No issues were noted with the function or operation of the table.The (b)(4) technician returned the table to service and no additional issues have been reported.(b)(4) performed in-service training on the proper use and operation of the 3085 sp surgical table.

Event Description

The user facility reported following a patient procedure, during patient transfer the 3085 sp surgical table began to tip.No report of injury.

• Brand Name: 3085SP 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: 7469559
• MDR Text Key: 107340070
• Report Number: 1043572-2018-00034
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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?: 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: 03/28/2018
• 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