MedWatch - The FDA Safety Information and Adverse Event Reporting Program
Stabilet Infant Warmer models 200, 300, 1250, 1500, 200/3000, 2000, 2200/3200, 3000, and 3200 [Draeger/Hill-Rom]
Audience: Pediatric and Obstetric Healthcare professionals, hospital risk managers
Draeger Medical and FDA notified healthcare professionals that it recommends the removal of Stabilet Infant Warmer models 200, 300, 1250, 1500, 200/3000, 2000, 2200/3200, 3000, and 3200 from service as soon as possible due to concern that continued use of these devices may result in serious injury to the patient and/or caregiver. A January 2008 fire in a Minnesota neonatal unit injured an infant and an independent investigation concluded that the Hill-Rom Stabilet 1250 was likely the ignition source of the fire. Draeger agrees with the recommendation to remove the referenced Stabilet models from service immediately. Immediate actions required include:
* Locate and identify the devices listed in this notice.
* Remove the referenced devices from service as soon as possible.
* If an infant is currently receiving therapy from one of the referenced devices, consider the risk of moving the patient before changing to an alternative mode of therapy.
* Once removed from service, the warmers should be rendered unusable by removing the heating element and the power cord. These warmers should not be used or sold for any other purpose.
A recall notification is being sent out to all known current users and is available in the Draeger website at www.draeger.com/Stabilet. Health care professionals and consumers should report serious adverse events (side effects) or product quality problems with the use of this product to Draeger Medical Systems Inc. or to the FDA MedWatch Adverse Event reporting Program, www.fda.gov/medwatch/report.htm
*Read the complete MedWatch 2009 Safety summary, including a link to the updated firm press release, click here.
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