| FDA: 100+ firmware-related medical-device issues so far this millenium |
| The FDA's Manufacturer and User Facility Device Experience (MAUDE) database lists over 100 product problems and adverse events related to firmware since the millenium began. Among the highlights are a microbial growth monitor which failed, allowing contaminated blood to be transfused to a patient; a cardiac device which failed to detect and treat actual tachycardia events while implanted in a patient. Note that most of the events reported in the database did not result in injury or adverse impact on the patient (save the occasional explant procedure). To view these and similar reports, search on the term "firmware" at <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/TextSearch.cfm>. |
