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

Device Problem Self-Activation or Keying (1557)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/16/2019

Event Type  malfunction  

Manufacturer Narrative

The table subject of the event was installed at the user facility in (b)(6) 1994 and is approximately 25 years old.A steris service technician arrived onsite to inspect the table and was unable to duplicate the reported event.The technician replaced the unit's trend cylinder, confirmed the unit to be operating according to specifications, and returned it to service.No additional issues have been reported.

Event Description

The user facility reported that during a patient procedure, their 3080 surgical table lowered into a level position without being commanded to do so.The user facility was able to immediately reposition the table with no report of injury or procedure delay.The procedure was completed successfully.

• Brand Name: 3080 SP 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: 9591986
• MDR Text Key: 208962094
• Report Number: 1043572-2020-00005
• 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: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2020
• 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
• Date Manufacturer Received: 12/16/2019
• 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