1. What: Philips HeartStart defibrillator. The HeartStart is an automated external defibrillator that is consist of a “computer with digital interface and cartridge containing pads.” 1 Recall Date: April 30, 2008 Why: The On/Off and Shock buttons on the device may stick in place when pressed and so it fail to respond when the button is pressed. This caused a “delay in the delivery of a defibrillation shock when the system advises a shock.” 1 Incidents: The defective was discovered during a testing and there has been no reported incidents during emergency use of HeartStart. Number of Units Sold: 389 When Sold: September 2005 1 Product Recall

2. Recognition of Problem: The HeartStart Defibrillators was manufactured by Philips in September 2005 and the button sticking in place was discovered during testing. It was found in a very small percentage of the affected units. Speed of Response: The response was slow because there was a three year interval from the time that the defibrillators was manufactured and the recall date. Responsibility: The company made a voluntary recall and contacted consumers to replace the defected product. 2 Management issues

3. Legal Consequence: It was a voluntary device recall and the government also listed the device for recall. No lawsuits could be found against Philips due to the HeartStart defibrillator defects. Reputation: The incident seems to have little affect on the reputation of Philips because there is no reported incidents. Sales: It cost the company money to replace all the devices that was defected. The government supported trial use of Philips HeartStart defibrillator for a $1,300 device approved for over-the-counter sale. 3 Impact Of Recall

4. 1. Class 2 Recall HeartStart defibrillator. (2010 Nov. 3). U.S. Department of Health & Human Services. Retrieved November 4, 2010, from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=7050 2 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=7050 2 2. Feder, Barnaby J. ( 2008, April 2). Study Finds Home Is No Help. The New York Times. 3. Philips Voluntary Device Recall. Philips Sense and Simplicity. Retrieved November 4, 2010. from http://www.healthcare.philips.com/in/products/resuscitation/hs1.wpd 4. Voluntary Recall for limited number of Philips HeartStart Home Defibrillators (Model M5068A). (2008, May 9). eMedAlert. Retrieved November 4, 2010, from http://www.drugstore.com/prescriptions/voluntary-recall-for-limited- number-of-philips-heartstart-home-defibrillators-model-m5068a-posted- 050908/qxc17433 http://www.drugstore.com/prescriptions/voluntary-recall-for-limited- number-of-philips-heartstart-home-defibrillators-model-m5068a-posted- 050908/qxc17433 4 References ETM 591 Joy Duong