MAUDE Adverse Event Report: SKYTRON KING-CORD; POWER CORD

Model Number KC-003

Device Problems Thermal Decomposition of Device (1071); Smoking (1585)

Patient Problem No Information (3190)

Event Date 02/12/2014

Event Type  malfunction  

Event Description

During the start of a surgical case, while positioning the anesthetized patient, the anesthesiologist noticed an electrical burning smell.The doctor noted burning and charring of the alternating current (ac) line cord where it entered the base of the surgery table.The doctor pulled and released the ac power cord from the table and notified the surgeon.The case proceeded with the operative room (or) table in its powered off position.The table was removed from service after the case and the biomedical department was notified to investigate.

• Brand Name: KING-CORD
• Type of Device: POWER CORD
• Manufacturer (Section D): SKYTRON; 5085 corporate exchange blvd s; grand rapids 49512 ; * 49512
• MDR Report Key: 3676500
• MDR Text Key: 4260250
• Report Number: 3676500
• Device Sequence Number: 2
• Product Code: FQO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 02/14/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Model Number: KC-003
• Device Lot Number: E85554
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/14/2014
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/13/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 25 YR