MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. PROAXIS® SPINAL SURGERY TABLE; TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED

Model Number	6988
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On november 1, 2024, hospital staff working in a storage area reported hearing unusual noises emanating from the direction of the pro-axis bed.Upon closer inspection, it was observed that smoke was rising from the base of the bed.Within seconds, additional smoke began to appear, accompanied by an acrid smell indicative of burnt electrical equipment.The pro-axis bed was immediately unplugged, and the bed was safely removed from the storage area to prevent further exposure to smoke and potential hazards.A visual inspection of the mizuho bed and its power cord was conducted, revealing no visible damage or signs of electrical burns.The bed has been removed from service and a request for repair of the mizuho bed has been placed, and we are currently awaiting the vendor's arrival on-site to conduct a thorough examination and necessary repairs.This incident appears to be isolated, as there have been no previous issues reported with the mizuho bed.

• Brand Name: PROAXIS® SPINAL SURGERY TABLE
• Common Device Name: TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern ave; union city CA 94587
• MDR Report Key: 20877898
• Report Number: 20877898
• Device Sequence Number: 19332927
• Product Code: JEA
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/27/2024
• Report Date (Section F): 11/27/2024

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 Model Number: 6988
• Device Catalogue Number: 6988
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 12/09/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/09/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 11/27/2024