U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Device malfunction-the self-test software may allow a self-test to clear a previously detected low battery condition. if this occurs, the operator may be unaware of the low battery and the device may be "unable" to deliver a defibrillation shock, which could result in failure to resuscitate a patient.
조치
Defibtech LLC initiated notification to customers/distributors on 2/17/07 by email. Hard copy letters followed on 2/22/07 with acknowledgement card. Users provided with instructions for 'Immediate Recommendations' until the unit''s software is upgraded.
Distributors, their customers, and direct accounts instructed to locate affected units and upgrade these units in the field. Distributors, their
customers, and direct accounts shall return to Defibtech documentation confirming unit
software upgrade was completed..Press was issued by the firm on March 6, 2007
Worldwide distribution ---- USA and countries of Canada, Uruguay, Jordon, Turkey United Kingdom, Saudi Arabia, Sweden France, South Africa, Cyprus, Spain, Germany India, Japan, Israel, Australia, Norway, Philppines Singapore, Poland, Germany, Italy, Switzerland Netherlands, Indonesia, United Arab Emirates Malaysia, Austria, Ireland, Kingdom of Bahrain, and Korea.
제품 설명
Defibtech Sentry Semi-Automatic External Defibrilator (AED) sold as 'Lifeline AED' brand -Model DDU-100A (version 2.002 and earlier)