MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY 3080 SP SURGICAL TABLE

Catalog Number B428793122

Device Problems Device Operates Differently Than Expected (2913); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/14/2014

Event Type  No Answer Provided  

Event Description

The user facility reported that during a patient procedure their surgical table does not stay in trendelenburg position.No injuries or procedural/delays/cancellations were reported.

Manufacturer Narrative

A steris service technician inspected the table and found it to be operating to specification; no issues were noted and the reported event was unable to be duplicated.The facility's biomed removed the table from service for testing.The biomed placed the table in full trend for 24-48 hours.In addition, weight was applied to the table and no movement was observed.The reported event was unable to be duplicated and the table was returned to service; no further issues have been reported.The table is approximately 21 years old and is serviced and maintained by the user facility.

• Brand Name: 3080 SP SURGICAL TABLE
• Type of Device: SURGICAL TABLE
• Manufacturer (Section D): STERIS CORPORATION - MONTGOMERY; 2720 gunter park east; montgomery AL 36109
• Manufacturer (Section G): STERIS CORPORATION - MONTGOMERY; 2720 gunter park east; montgomery AL 36109
• Manufacturer Contact: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 3832296
• MDR Text Key: 4393643
• Report Number: 1043572-2014-00043
• 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: 05/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: B428793122
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2014
• 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
• Patient Outcome(s): Other