Featured KidNet Report of Interest
MedSun: Newsletter #48, May 2010

Your reports of actual adverse events, and more importantly, reports of 'potential for harm,' 'near miss,' and 'close call' medical device related safety concerns are of special interest to FDA, MedSun and KidNet. Potential for harm, near miss and close calls may be related to human factors issues such as incomplete or confusing instructions for use, labeling that is too small to read or unable to be easily seen by the user, or device design, i.e., ‘double bouncing’ keys, or inaudible alarms. Events that don’t involve patients or caregivers directly are particularly valuable as they represent an opportunity to address a problem before an injury occurs.

The following event reported by a MedSun KidNet facility of a ‘potential for harm’ event resulted in manufacturer action:

Type of Device: Infant Warmer
Device Manufacturer’s Name: Draeger Medical Systems, Inc.
Date of this report: May 2, 2008

Reported Event: An infant warmer ignited while the unit was in the operating room pending delivery of the infant. The unit was in operation but the infant was not in the bed. A manufacturer’s representative came to the facility to replace parts on the damaged unit and will be replacing the heater elements on all units in the facility.

Related Recall:This event contributed to a Class 2 recall posted August 26, 2009 for the heater elements on Resuscitaire Infant Radiant model numbers RW82, RW82 VHA, WBR82, and WMRW82 - 120 volt configuration only - manufactured Draeger Medical Systems. The reason for this recall is a mis-positioned crimp on heater element lead wire resulted in flame and smoke aerating from the top of the warmer assembly. To read the FDA recall notice, see link provided under Addition Information below.

If you become aware of problems with devices indicated for use with neonatal or pediatric patients that fail or don’t perform as intended, or represent a potential for harm, please report these events through your MedSun representative if you’re a member of MedSun or KidNet, or through your hospital’s reporting policy.

If you are not affiliated with a hospital, you can submit a voluntary report online through MedWatch at http://www.fda.gov/medwatch/index.html. Together, we can make recognition and reporting of actual and potential medical device-related adverse events a model for patient safety.

Additional Information:

Medical Device Recall. Class 2 Recall: Heater Elements for Resuscitaire Infant Radiant Warmers. August 26, 2009.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=84109.

MedSun Report. May 2, 2008. Online Available:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/medsun_details.cfm?ID=%25%22%2D%5F%3C%26%5F%3C%20%0A


MedSun Newsletters are available at www.fda.gov/cdrh/medsun