Events

Recall of Device Recall Olympic CoolCap System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Natus Medical Incorporated.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    61946
  • Event Risk Class
    Class 2
  • Event Number
    Z-1843-2012
  • Event Initiated Date
    2012-05-21
  • Event Date Posted
    2012-06-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-02-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109564
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Cooling Cap ( Infants ) - Product Code MXM
  • Reason
    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.
  • 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.

Device

Device Recall Olympic CoolCap System
  • Model / Serial
    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.
  • Product Classification
    Neurological Devices
  • Device Class
    3
  • Implanted device?
    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.
  • Product Description
    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
    Natus Medical Incorporated

Manufacturer

Natus Medical Incorporated
  • Manufacturer Address
    Natus Medical Incorporated, 5900 1st Ave S, Seattle WA 98108-3248
  • Manufacturer Parent Company (2017)
    Natus Medical Incorporated
  • Source
    USFDA