MAUDE Adverse Event Report: MIZUHO SKYTRON; SURGICAL TABLE

Model Number 3500B

Device Problem Maintenance Does Not Comply To Manufacturers Recommendations (2974)

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

Event Date 02/01/2015

Event Type  malfunction  

Event Description

During a mid-craniotomy, the staff noted a smoke odor coming from the surgical table.They pulled back the drapes and noted smoke and saw that the power cord came unplugged from the table.The procedure was delayed as biomed had to be called to evaluate the table.Neither patient or providers suffered any serious injury.Upon initial investigation, facility is not using oem part, which may have contributed to the event.

• Brand Name: SKYTRON
• Type of Device: SURGICAL TABLE
• Manufacturer (Section D): MIZUHO; tokyo ; JA
• Manufacturer (Section G): SKYTRON, DIV. THE KMW GROUP, INC.; 5000 36th st., s.e.; grand rapids MI 49512
• Manufacturer Contact: 5000 36th st., s.e.; grand rapids, MI 49512
• MDR Report Key: 4626640
• MDR Text Key: 5656132
• Report Number: 1825014-2015-00001
• Device Sequence Number: 1
• Product Code: JEA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial
• Report Date: 03/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3500B
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/13/2015
• Distributor Facility Aware Date: 02/27/2015
• Device Age: 11 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/13/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1