MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. PROFX TABLE; SURGICAL TABLE

Model Number 6850

Device Problem Device Issue (2379)

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

Event Date 06/08/2016

Event Type  malfunction  

Event Description

Patient was ready to be moved from the operating room table to her bed for transport to pacu.Just prior to transferring patient, the head of the bed was lowered via bed control remote to flatten the bed.Upon releasing the button, the head of the bed continued to move downward on its own, placing the patient in an unintentional steep trendelenburg position.Button pressed on remote to reverse/stop position with no success.Head of bed stopped moving on its own.

Manufacturer Narrative

Hand pendant was shorting on the connector end where it plugs into the table due to exposed wires on the outside of the hand pendant causing the table to lose control functions.This was readily apparent to the customer and fse.Customer discarded hand pendant and the hand pendant was not sent back via rga.

Event Description

Patient was ready to be moved from the operation room table to her bed for transport to pacu.Just prior to transferring patient, the head of the bed was lowered via bed control remote to flatten the bed.Upon releasing the button, the head of the bed continued to move downward on its own, placing the patient in an unintentional steep trendelenburg position.Button pressed on remote to reverse/stop position with no success.Head of bed stopped moving on its own.

• Brand Name: PROFX TABLE
• Type of Device: SURGICAL TABLE
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city CA 94587 1234
• Manufacturer (Section G): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city CA 94587 1234
• Manufacturer Contact: anne leblanc ; 30031 ahern avenue; union city, CA 94587-1234 ; 5104291500
• MDR Report Key: 5836748
• MDR Text Key: 50852761
• Report Number: 2921578-2016-00013
• 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: other
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 10/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6850
• Device Catalogue Number: 6850
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2006
• 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