MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY OT1200 SURGICAL TABLE

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 08/28/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation of this event is currently in process.A follow-up report will be submitted when additional information becomes available.

Event Description

The user facility reported that their hand control would not respond to commands during a patient procedure.

Manufacturer Narrative

The user facility reported that the patient present during the time of the reported event was positioned in a way that caused the patient to roll off the table.The user facility also stated that the patient was taped to the surgical during the time of the reported event.The patient was not secured to the surgical table with safety straps.The patient received medical treatment.The operator manual states (pp.1-2), "failure to keep the patient properly secured with the patient safety straps at all times could result in death or serious injury." a steris service technician arrived onsite to inspect the surgical table and found that the table was unresponsive to hand control commands due to the wiring to the tilt solenoids becoming tangled within hydraulic lines.Although this issue was observed, the steris technician stated this would not have caused a significant amount of movement for a patient within the weight limits to roll off the table.The technician repaired the surgical table, tested it and returned the table to service.The user facility received in-service training on properly securing patients to the surgical table during procedures.No additional issues have been reported.

• Brand Name: OT1200 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: 6905184
• MDR Text Key: 89514108
• Report Number: 1043572-2017-00066
• Device Sequence Number: 1
• Product Code: JEA
• 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,Followup
• Report Date: 09/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2017
• 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
• Date Manufacturer Received: 08/30/2017
• 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