MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. RADIOLUCENT IMAGING TOP W/GIMBALS (500 LBS); TABLE SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED

Model Number 5803

Device Problems Unintended System Motion (1430); Device Operates Differently Than Expected (2913)

Patient Problem Fall (1848)

Event Date 08/04/2014

Event Type  malfunction  

Event Description

The hospital's charge nurse called that last night toward the end of an aaa case, the anesthesiologist want to tilt the table, using the hand remote, and according the anesthesiologist, when he/she did so, the table rotated quickly past what it normally does.The patient was strapped in with a safety strap and (b)(6) called it an "assisted fall" to the ground.The patient was beginning to gain consciousness at this point and was extubated as a result of the "fall".Injuries to the patient are unknown.The anesthesiologist claims that both the rotation locks were on at this point.(b)(6) is unsure if this was user error or equipment malfunction and wants the table inspected to determine if there are any mechanical problems with the table.She is taking it out of use until it is inspected (not sure which of the 3 tables this hospital owns that was involved in this incident).Possible serial number serial numbers, (b)(4).

• Brand Name: RADIOLUCENT IMAGING TOP W/GIMBALS (500 LBS)
• Type of Device: TABLE SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern ave.; union city CA 94587 123
• Manufacturer (Section G): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern ave.; union city CA 94587 123
• Manufacturer Contact: kirke jayne ; 30031 ahern ave.; union city, CA 94587-1234 ; 5104291500
• MDR Report Key: 4202633
• MDR Text Key: 5146421
• Report Number: 2921578-2014-00023
• 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,Company Representative
• Reporter Occupation: Nurse
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 08/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 08/05/2014
• Initial Date FDA Received: 08/20/2014
• Was Device Evaluated by Manufacturer?: No
• 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