MAUDE Adverse Event Report: MIZUHO MEDICAL SKYTRON; SURGICAL TABLE

Model Number 3600B

Device Problems Fire (1245); Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/21/2015

Event Type  malfunction  

Event Description

Response to report # (b)(4).Skytron reached out to the risk management specialist at (b)(6).We were informed that no injuries were reported and the case was able to be completed as scheduled.The facility is using a non-oem power cord.The defective parts had been disposed of by the facility.Without the parts for evaluation a conclusive cause to the incident cannot be determined.However, the use of non-oem cords creates a risk of fluid ingress.Oem cords are specially designed to create a water tight seal reducing the risk of fluid ingress.In a photo provide to us from the facility, fluid was found at the connector end of the power cord that goes into the table.This ingress could create a short causing the smoke.The facility has replaced the defective connector and the power cord with an oem connector and power cord.

• Brand Name: SKYTRON
• Type of Device: SURGICAL TABLE
• Manufacturer (Section D): MIZUHO MEDICAL; hongo shintoku bldg. 7f; 3-38-1, hongo; bukyo-ku, 113-0 033; JA 113-0033
• MDR Report Key: 5285423
• MDR Text Key: 33143949
• Report Number: 1825014-2015-00055
• Device Sequence Number: 1
• Product Code: GDC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3600B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/09/2015
• Distributor Facility Aware Date: 11/12/2015
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/10/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1