Press Release
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No. 2us / Jan. 14, 2008
Draeger Medical Systems, Inc. responds to ECRI Institute report regarding Minnesota Hospital incident
Telford, PA (January 14, 2009) – Draeger Medical Systems, Inc. is aware of the ECRI report released today and wishes to provide the following response and clarification on the events leading up to the release of the organization’s report.
On January 22, 2008, a brief, intense fire in the neonatal unit of a hospital in Minnesota injured a full-term infant. At the time of the fire, the infant was in a bassinet beneath a “Stabilet” infant warmer, model number 1250, manufactured in 1994 by Hill-Rom Co., Inc. (“Hill-Rom”). Following a June 2004 sale, Dräger acquired Hill-Rom’s Stabilet product line of radiant infant warmers, including models 200, 300, 1250, 1500, 200/3000, 2000, 2200/3200, 3000, and 3200 (collectively, “Stabilet Infant Warmer”). Over the manufacturing life of the product, approximately 4000 Stabilet units were sold, primarily in the US and Canada. Hill-Rom discontinued manufacturing the Stabilet product line in 1998, six years before the sale to Dräger.
In 1994, Hill-Rom issued a voluntary recall of Stabilet Infant Warmers based on a single reported instance of “arcing” due to corrosion of the stainless steel heater contacts, which resulted in a small piece of heated material falling into the bassinet. Hill-Rom sent out a notification to users of the Stabilet, as well as a kit containing a protective heater cover and instructions on how to install it beneath the heater contacts. The notice specifically instructed users to retrofit their Stabilet units in the field with the protective heater cover to prevent the possibility of any materials falling into the bassinet. Such a protective heater cover had been installed and was present on the Stabilet at issue in the recent Minnesota incident. The recall and the protective heater cover retrofit kit were fully disclosed to the FDA.
Following the January 22, 2008 incident, the hospital hired ECRI Institute and others (collectively, “ECRI”) to investigate. ECRI’s investigation posited a number of theories as to the root cause of the ignition source for the fire. Since there was no surviving evidence to confirm conclusively the correctness of any of the competing theories, ECRI could only hypothesize as to the root cause of the ignition source. ECRI has now published some conclusions from its report that point to the Stabilet itself as a possible ignition source for the fire..
It’s important to note that the hospital has not allowed Dräger to independently test and evaluate the evidence collected concerning the incident. Only the hospital’s hired experts have been given such access.
Dräger takes this matter seriously and is following it closely. Dräger has retained its own expert both to analyze the ECRI report, and to conduct any additional investigations that may be needed to determine the cause of the fire.
The safety of infants and the warming systems that protect them is a top priority for Dräger. We believe all Stabilet Infant Warmers that have been retrofitted with the protective heater cover are safe and effective when used as directed.
Dräger. Technology for Life®
The Drägerwerk AG & Co. KGaA is an international leader in the fields of medical and safety technology. Dräger products protect, support and save lives. Founded in 1889, in 2007 Dräger generated revenues of around EUR 1.8 billion. The Dräger Group is currently present in more than 190 countries and has about 10,000 employees worldwide. Please visit www.draeger.com for more information.
Investor Relations, Vanina Herbst, Tel: +49 451 882 2685, E-Mail: