| Date Initiated by Firm |
May 21, 2012 |
| Date Posted |
June 20, 2012 |
| Recall Status1 |
Terminated 3 on February 21, 2014 |
| Recall Number |
Z-1843-2012 |
| Recall Event ID |
61946 |
| PMA Number |
P040025 |
| Product Classification |
Cooling Cap ( 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 WA 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 |
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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| PMA Database |
PMAs with Product Code = MXM and Original Applicant = Natus Medical Incorporated
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