MEDI-TRACE CADENCE

Additional Manufacturer Narrative

AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

Description of Event or Problem

THE CUSTOMER REPORTED THERE WAS A PATIENT IN VFIB REQUIRING DEFIBRILLATION, PADS PUT ON PATIENT AND SHOCKED C 200J. AUDIBLE POPPING AND NOISE HEARD, SMELL OF SOMETHING BURNING/SMOKING. PATIENT SUCCESSFULLY DEFIBRILLATED.

Additional Manufacturer Narrative

A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT PERFORMED DURING THIS INVESTIGATION AS THE LOT NUMBER WAS NOT RECEIVED WITH THE COMPLAINT. PRIOR TO A LOT¿S RELEASE, THE LOT MUST BE DEEMED ACCEPTABLE BY-PASSING INSPECTIONS THAT ARE BASED ON A VALID SAMPLING PLAN. DURING PRODUCTION, INSPECTORS ROUTINELY EXAMINE A STATISTICAL SAMPLE BOTH PHYSICALLY AND VISUALLY. BECAUSE THERE WAS NO LOT NUMBER PROVIDED, THE DATE OF MANUFACTURE COULD NOT BE DETERMINED. ONE SET OF ELECTRODES WERE RECEIVED FOR EVALUATION. THE ELECTRODES WERE RECEIVED FOLDED IN HALF. UPON INSPECTION OF THE ELECTRODE SET, IT WAS NOTED THAT THE ELECTRODES WERE ALMOST COMPLETELY DRIED OUT AND WOULD NOT STICK TOGETHER ENOUGH TO PERFORM ELECTRICAL TESTING ON THE PRODUCT. VISUAL INSPECTION SHOWED A LOT OF HAIR AROUND THE FOAM AND GEL PORTIONS OF THE ELECTRODES. THERE WAS ALSO WHAT APPEARS TO BE A SOOT MARK IN THE UPPER RIGHT CORNER OF ONE OF THE ELECTRODES. THE PADS WERE INSPECTED TO SEE IF THERE WERE ANY LOOSE WIRES, STRAY WIRE FIBERS, OR FOAM, AND WIRE RESTRAINTS WERE IN PLACE. THE WIRE MATS APPEAR TO BE PRESENT AND IN THE CORRECT PLACEMENT. ALTHOUGH THERE APPEARS TO BE SOOT MARKS, IT WAS NOT POSSIBLE TO DETERMINE, BASED ON THE SAMPLE AND EVALUATION, WHAT CAUSED THEM. WITH NO DAMAGE OR DEFECTS IN THE ELECTRODES, WIRES OR MATERIALS AND THE PRESENCE OF DEBRIS ON THE PRODUCT THE REPORTED ISSUE WAS NOT ABLE TO BE CONFIRMED BASED ON THE SAMPLE EVALUATION. IT IS IMPORTANT TO FOLLOW ALL SAFETY GUIDELINES AND INSTRUCTIONS FOR USE (IFU) WHILE USING THE ELECTRODES. CARE SHOULD BE TAKEN TO PROPERLY PREPARE THE PATIENT SKIN PRIOR TO ELECTRODE APPLICATION. TO HELP THE ELECTRODE MAKE GOOD SKIN CONTACT AND TO HELP REDUCE CONTACT IMPEDANCE THE PRODUCT LABELING INSTRUCTIONS AND WARNINGS SHOULD BE FOLLOWED. THE RESULTS OF THE MANUFACTURING FACILITY INVESTIGATION WERE UNABLE TO ATTRIBUTE ANY POTENTIAL ROOT CAUSES ASSOCIATED WITH THE MANUFACTURE OF PRODUCT. BASED UPON THE INVESTIGATIVE DETAILS AND THE ROOT CAUSE EVALUATION, NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED. WE WILL CONTINUE TO MONITOR RELATED REPORTS TO DETERMINE IF ADDITIONAL ACTIONS ARE NECESSARY.