Device Recall Olympic CoolCap System

  • Modèle / numéro de série
    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.
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • 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.
  • Description du dispositif
    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***"
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Natus Medical Incorporated, 5900 1st Ave S, Seattle WA 98108-3248
  • Société-mère du fabricant (2017)
  • Source
    USFDA