Retiro De Equipo (Recall) de Device Recall Olympic CoolCap System

Recall

61946

Class 2

Z-1843-2012

2012-05-21

2012-06-20

Terminated

United States

2014-02-21

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109564

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.

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.