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

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 04/29/2015

Event Type  No Answer Provided  

Event Description

Social media monitoring identified the following post on www.Medwrench.Com: "does anyone know what error code sensor fail 17 pertains to on this table? which sensor may need maintenance when error code sensor fail 17 is displayed on the hand control unit lcd?".

Manufacturer Narrative

Steris monitors relevant websites and social media sources per our social media policy to identify potential complaints.Through this process, steris identified a post from a user under the name (b)(6) about an error code sensor fail 17.A steris social media monitoring representative replied to the post on (b)(6) 2015: "dear (b)(6), we came across your post about the steris 4085 general surgical table.We have a dedicated service support team who can help.Please provide us with your preferred method of contact or call (b)(4) for assistance.Thank you." the operator manual states (pp.A-8), "lcd screen wrench number 17: alarm-height sensor failure.Combination movements (level, flex and reflex) are not allowed." as the complainant has not responded to our follow up post, steris is unable to determine if the reported hand control sensor fail occurred during a patient procedure.It is also unknown if an injury, and/or procedural delay or cancellation occurred.A follow-up report will be submitted if additional information becomes available.

• Brand Name: 4085 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: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 4799364
• MDR Text Key: 5880528
• Report Number: 1043572-2015-00050
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2015
• Was Device Evaluated by Manufacturer?: No
• 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