一級回收 Stabilet Infant Warmer models 200, 300, 1250, 1500, 200/3000, 2000, 2200/3200, 3000, and 3200 [Dräeger/Hill-Rom]

(http://bme.freebbs.tw 醫學工程論壇同步發表)

 

 

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm173239.htm

己停產的設備，如果仍有在使用的，Drager己發通知請勿使用，也不要再轉賣或是捐贈

Stabilet Infant Warmer models 200, 300, 1250, 1500, 200/3000, 2000, 2200/3200, 3000, and 3200 [Dräeger/Hill-Rom]

Audience: Pediatric and Obstetric Healthcare professionals, hospital risk managers

[UPDATED 08/25/2009] FDA notified healthcare professionals of a Class 1 recall of these models of the Stabilet infant warmer because these out-of-date devices may cause serious injury to infants and caregivers due to the possibility that the warmer might be the ignition source for a fire. On July 20, 2009, Draeger sent a recall letter to all known customers, requested customers remove the affected devices from service, remove the heating element and the power cord to make the device unusable once removed from service and emphasized these devices are not to be used, donated or sold for any other purpose. Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.

[Posted 07/22/2009] 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.
• 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.
• 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.

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's MedWatch Adverse Event reporting Program (www.fda.gov/medwatch/report.htm)

[08/25/2009 - Recall Notice - FDA]
[07/20/2009 - Press Release - Draeger]