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U.S. Department of Health and Human Services

Class 2 Device Recall Olympic CoolCap System

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 Class 2 Recall
Olympic CoolCap System
see related information
Date Posted June 20, 2012
Recall Status1 Terminated on February 21, 2014
Recall Number Z-1843-2012
Recall Event ID 61946
Premarket Approval
PMA Number
P040025
Product Classification Cap,Cooling (Infants) - Product Code MXM
Product Olympic Cool-Cap System is intended to provide treatment for neonatal hypoxic-ischemic encephalopathy (HIE). The Cool-Cap is indicated for use in full term infants (more than 36 week gestational age) with clinical evidence of moderate to severe HIE. The device provides selective head cooling with mild systemic hypothermia to prevent or reduce the severity of neurologic injury associated with HIE. It is a selective head cooling system for treatment of neonatal hypoxic-ischemic encephalopathy (HIE) in infants. A cooling water cap is placed on the infant's head and the body is warmed using radiant warmers. The Cool-Cap provides 72 hours of monitored cooling. The device is labeled in part: "***OLYMPIC COOL-CAP Cooling Unit***Model No.***Made in USA***Software in this product is Natus Medical Incorporated***"
Code Information Cooling Serial Numbers: 1008; 1009; 1011; 1012; 1014; 1016; 1017; 1018; 1020; 1021; 1022; 1023; 1024; 1025; 1027; 1028; 1030; 1031; 1034; 1035; 1036; 1038; 1044; 1045; 1048; 1050; 1051; 1052; 1053; 1054; 1055; 1056; 1059; 1060; 1062; 1063; 1064; 1065; 1066; 1070; 1071; 1072; 1073; 1074; 1075; 1076; 1077; 1080; 1081; 1082; 1083; 1085; 1086; 1087; 1088; 1090; 1091; 1092; 1093; 1094; 1095; 1096; 1097; 1101; 1116; 1117; 1118; 1119; 1120; 1122; 1124; 1125; 1126; 1127; 1128; 1129; 1130; 1131; 1132; 1136; 1137; 1138; 1139; 1141; 7002; 7003; 7004; 7005; 7007; 7008; 7009; 7010; 7011; 7013; 7014; 7016; 7017; 7018; 7019; 7020; 7021; 7022; 7023; 7024; 7025; 7026; 7027; 7028; 7030; 7031; 7032; 7033; 7034; 7036; 7037; 7038; 7039; 7040; 7041; 7042; 7043; 7044; 7045; 7046; 7047; 7048; 7049; 7051; 7052; 7053; 7054; 7055; 7250; 7251; 7252; 7253; 7255; 7256; 7257; 7258; 7259; 7260; 7261; 7262; 7263; 7264; 7265; 7266; 7267; 7268; 7269; 7270; 7271; 7272; 7273; 7274; 7275; 7276; 7277; 7278; 7279; 7280; 7281; 7282; 7283; 7284; 7285; 7286; 7288; 7289; 7290; 7291; 7292; 7293; 7294; 7363; 7364; 7365; 7366; 7372; and 7374.
Recalling Firm/
Manufacturer
Natus Medical Incorporated
5900 1st Ave S
Seattle, Washington 98108-3248
For Additional Information Contact Natus Medical Incorporated
888-496-2887
Manufacturer Reason
for Recall
Olympic Cool-Cap Cooling Module's power supply failed during treatment. The power supply failure can happen without prior indication and results in the unavailability of the system to begin or continue cooling treatment.
FDA Determined
Cause 2
DESIGN: Component Design/Selection
Action Natus Medical Incorporated sent a URGENT: MEDICAL DEVICE FIELD CORRECTIVE ACTIONS Olympic Cool-Cap System letter dated May 21, 2012, to all affected customers. Fed-Ex to all U.S. customers, specifically to Biomedical department, NICU, with affected devices. The letter identified the product the problem and the action needed to be taken by the customer. In addition, Natus also sent the Urgent Field Safety Notice-Olympic Cool-Cap System (DOC-007459) dated May 2012 to all US customers and International Distribution Partners who were affected by both Frozen Screen and Power Supply field corrective action. Customers were instructed to: " During all routine checks of infants undergoing treatment, look at the clock displayed on the screen to verify that the seconds counter on the clock is advancing. The time displayed should continue to advance if the system is operating correctly. " If the system experiences a screen-freeze during a cooling session, the Olympic Cool-Cap system can be rebooted and cooling resumed. " Ensure that all the personnel in your facility that use the Olympic Cool-Cap system are advised of this Field Safety Notice (see attached). The U.S. customers are advised of the issue specifically stated in Action #2 in the letter and they are also informed that Natus will contact them within the next 30 to 120 days to schedule the power supply replacement in their affected system(s). Natus requires that the Distribution Partners to notify their customers with copies of the Natus recall letter and the Field Safety Notice (DOC-007459). Specifically these two documents should be addressed to both the Biomedical Department and the Neonatal Intensive Care Unit (NICU). Customers with questions about this recall should call Natus Technical Service at 888-496-2887 or email to TService@natus.com.
Quantity in Commerce 181 units
Distribution Worldwide Distribution -- USA (nationwide) including the states of : AK; AR; AZ; CA; CO; DE; FL; GA; HI; ID; IL; IN; KY; MA; MI; MN; MS; ND; NE; NJ; NY; OH; PA; SC; SD; TN; TX; and WA. and the countries of : Argentina; Australia; Austria; Canada; Egypt; Germany; Hong Kong; Indonesia; Iran; Italy; Kuwait; Poland; Russia; Saudi Arabia; Singapore; Slovenia; South Africa; South Korea; Spain; Taiwan; Thailand; Turkey; United Arab Emirates; and United Kingdom.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = MXM and Applicant = NATUS MEDICAL INCORPORATED
PMAs with Product Code = MXM and Applicant = NATUS MEDICAL, INC.
PMAs with Product Code = MXM and Applicant = OLYMPIC MEDICAL CORP.
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