Additional Manufacturer Narrative · 1
THE EXPIRATORY CURRENT SERVO PC1585/1586 WAS REPLACED AND THE VENTILATOR WAS RESTORED TO WORKING CONDITION. THE PC1585 HAD NO VISIBLE DAMAGE BUT PC1586 WAS FOUND WITH FAULTY CAPACITORS C2 AND C4 AND A TRANSISTOR T2 HAD SHORT CIRCUITED. THE INDUCTOR COIL L1 PLASTIC COATING HAD MELTED AWAY RESULTING IN THE BURNING SMELL. THE MOST PROBABLE CAUSE WAS THE FAILING OF THE CAPACITATORS C2 AND C4 ON PC1586 MOST PROBABLY DUE TO A CURRENT SURGE. THE FAILING OF T2 AND OVERHEATING OF L1 WAS A RESULT OF THE RESULTING HIGH CURRENT FLOWS AFTER INITIAL FAILING OF THE CAPACITATORS. OVERHEATING OF THE COMPONENT L1 CAN LEAD TO GENERATION OF SMOKE BUT WILL NOT LEAD TO SUSTAINED FIRE. THE VENTILATOR MATERIAL SELF EXTINGUISHES IN AIR. AN IMPROVED CURRENT SERVO WHICH WITHSTANDS HIGHER CURRENTS WITH AN ADDITIONAL PROTECTIVE FUNCTIONALITY THAT LIMITS THE CURRENT IN CASE OF COMPONENT FAILURE AND REDUCES THE LIKELIHOOD OF OVER HEATED AND SMOKING COMPONENTS WAS IMPLEMENTED IN PRODUCTION AND AS SPARE PARTS IN JUNE 2002. MAQUET INC. SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MFG FACILITY. MAQUET CRITICAL CARE AB PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.