FDA Adverse Event Malfunction Summary report: N

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MDR report key: 2723113 · Received August 27, 2012

Report

Report Number
2723113
Event Type
Malfunction
Date Received
August 27, 2012
Date of Event
April 6, 2012
Report Date
August 27, 2012
Manufacturer
GETINGE CASTLE USA
Product Code
LGZ
Product Problem
Yes
Report Source
User Facility report
Reporter Location
MI, US

Narratives

Description of Event or Problem · 1

DEVICE INVOLVED WAS A GETINGE/CASTLE USA BLANKET WARMER, MODEL 5540. THE MOU MED ROOM BEGAN FILLING UP WITH SMOKE. SMOKE WAS FOUND TO BE COMING FROM THE BLANKET WARMER. SECURITY AND MAINTENANCE WERE NOTIFIED AND RESPONDED ASAP. PT'S NEEDED TO BE MOVED FROM THAT AREA TO ANOTHER PART OF MOU. THE CASING FOR THE WARMER WAS REMOVED DURING SERVICE TO IDENTIFY THE SOURCE OF THE PROBLEM. A 120 VOLT, 15AMP SOLID STATE RELAY (15SA ) THAT CONTROLS THE HEATING CYCLE WAS FOUND TO BE CHARRED AND SHOWED OBVIOUS SIGNS OF OVERHEATING. THE WIRING AND ALL OTHER COMPONENTS ON THE CIRCUIT BOARDS WERE VISUALLY INSPECTED AND SHOWED NO SIGNS OF OVERHEATING OR DAMAGE. THERE WAS NO FIRE DURING THE INCIDENT BUT THE OVERHEATING OF THE RELAY WAS THE CAUSE OF THE SMOKE AND ODOR THAT WAS REPORTED BY MOU. THE WORK ORDER HISTORIES FOR THE OTHER 3 WARMERS OF THE SAME MODEL 5540 IN OUR INVENTORY WERE REVIEWED FOR SIMILAR PROBLEMS OR COMPLAINTS AND NONE WERE FOUND. THE MANUFACTURER OF THE WARMER, GETINGE/CASTLE USA, WAS ALSO CONTACTED TO REPORT THE PROBLEM. THEY CHECKED THEIR RECORDS TO VERIFY THAT THERE WERE NO OTHER REPORTED PROBLEMS OR ISSUES WITH THIS OCCURRING ON OTHER UNITS AND SUSPECTED THIS WAS AN ISOLATED PROBLEM. THE RELAY WAS REPLACED WITH A NEW ONE. THE WARMER PASSED ALL FUNCTIONAL AND ELECTRICAL SAFETY TESTING. THE WARMER WAS LEFT ON IN THE SERVICE SHOP OVER 36 HOURS TO VERIFY ITS PERFORMANCE BEFORE IT WAS RETURNED BACK TO THE DEPARTMENT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 * BLANKET, WARMER LGZ GETINGE CASTLE USA * *

Patients

Seq Age Sex Outcome Treatment
1 *