MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. MODULAR TABLE ADVANCED CONTROL "I" BASE; OPERATING TABLE

Model Number 5803

Device Problems Unintended System Motion (1430); Device Issue (2379)

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

Event Date 12/06/2017

Event Type  malfunction  

Manufacturer Narrative

During the service call to investigate this event it was discovered that preventive maintenance on the table was completed by an untrained 3rd party.Examination of the table by the mizuho osi service engineer found no problems with table, no issues with table foot end brake, and the 180 degree rotation safety lock functions were all working properly.

Event Description

It was reported to mizuho osi that during surgery the table tilted unexpectedly, putting the patient at risk of falling off the table.

• Brand Name: MODULAR TABLE ADVANCED CONTROL "I" BASE
• Type of Device: OPERATING 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: 7247915
• MDR Text Key: 99814374
• Report Number: 2921578-2018-00001
• 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: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5803
• Device Catalogue Number: 5803
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2012
• 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 Age: 52 YR