February 2008, Volume 38 Number 2 , p 17 - 17
Sullivan, Roberta RN, BSN, MPH; Ferriter, Ann BS
Roberta Sullivan is a nurse-consultant and Ann Ferriter is an issue manager at the Center for Devices and Radiological Health. Although you need to support your health care facility's adverse event—reporting policy, you may voluntarily report a medical device that doesn't perform as intended by contacting MedWatch at 1-800-FDA-1088 (fax: 1-800-FDA-0178) or online at http://www.fda.gov/medwatch/how.htm . The opinions and statements in this report are those of the authors and may not reflect the views of the Department of Health and Human Services. Beverly Albrecht Gallauresi, RN, BS, MPH, who coordinates Device Safety , is a cardiovascular nurse-consultant at the Center for Devices and Radiological Health at the Food and Drug Administration in Rockville, Md. Web sites last accessed on January 2, 2008.
A MIDDLE-AGED MAN died after uneventful elective surgery because no one turned his implantable cardioverter ...