MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. ADVANCED CONTROL I-BASE, DC; SURGICAL OPERATING TABLE

Model Number 5803

Device Problems Unintended System Motion (1430); Electrical Shorting (2926); Device Fell (4014)

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

Event Date 01/15/2020

Event Type  malfunction  

Event Description

It was reported the table dropped and was supported by the c-arm.There was a patient on the table but there were no injuries.

Event Description

It was reported the table dropped and was supported by the c-arm.There was a patient on the table but there were no injuries.

Manufacturer Narrative

The root cause of the table is due to neglect and abuse.Customer did not provide table for servicing for preventative maintenance.The condition of the table is concerning, rust on the table base by the ac power entry module, the ac power entry module was loose and coming out from its housing, the hand pendant cable insulation was damaged and the wires were making contact is the root cause of why the table was not currently functioning, tightened the blue handle and adjusted switch, adjusted the head-end side friction, tightened base plate trolley screws and both column motors are loose (already recommended to replace columns, needs two casters replaced).Facility should have been aware of the obviously exposed wires and they should have red tagged the table for service before conducting additional procedures."per the owner's manual, before and after each use of the advanced control base, visually inspect all accessible areas, electrical cords and all movable parts for possible damage that may adversely affect the proper operation of the base.Damaged or defective products should not be used or processed.Contact mizuho osi service for repair or replacement".

• Brand Name: ADVANCED CONTROL I-BASE, DC
• Type of Device: SURGICAL OPERATING TABLE
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city, ca CA 94587 1234
• MDR Report Key: 9608299
• MDR Text Key: 183889516
• Report Number: 2921578-2020-00007
• Device Sequence Number: 1
• Product Code: JEA
• UDI-Device Identifier: 00842430106026
• UDI-Public: 00842430106026
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 03/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2020
• 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
• Date Manufacturer Received: 01/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1