{"id":4450,"date":"2019-06-07T14:42:38","date_gmt":"2019-06-07T18:42:38","guid":{"rendered":"https:\/\/midstateems.dreamhosters.com\/blog\/?p=4450"},"modified":"2019-06-07T14:42:58","modified_gmt":"2019-06-07T18:42:58","slug":"zoll-electrodes","status":"publish","type":"post","link":"https:\/\/midstateems.dreamhosters.com\/blog\/2019\/06\/07\/zoll-electrodes\/","title":{"rendered":"Zoll Electrodes"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">[High\nPriority ] &#8211; A32793 : ZOLL\u00e2\u20ac\u201dPro-padz Liquid Gel Radiolucent Electrodes Used with\nZOLL R, M, E, and X Series Defibrillators: May Prevent<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Delivery of Defibrillation or Pacing\nTherapy<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>[High Priority ] &#8211; A32793 : ZOLL\u00e2\u20ac\u201dPro-padz Liquid Gel Radiolucent Electrodes\nUsed with ZOLL R, M,<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>E, and X Series Defibrillators: May Prevent Delivery of Defibrillation\nor Pacing Therapy<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Medical Device Ongoing Action<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Published: <\/strong>Monday, June\n3, 2019 <strong>Last Updated: <\/strong>Wednesday, June 5, 2019<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>UMDNS\nTerms:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Electrodes, Cardiac, External Defibrillator\n[15033]<\/li><li>Defibrillator\/Cardioverters&nbsp; [18502] <strong>Product\nIdentifier:<\/strong><\/li><\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">[Capital Equipment, Consumable]<\/p>\n\n\n\n<table class=\"wp-block-table\"><tbody><tr><td>\n  <strong>Product<\/strong>\n  <\/td><td>\n  <strong>ZOLL Medical Corp Part No.<\/strong>\n  <\/td><td>\n  <strong>Lot No.<\/strong>\n  <\/td><\/tr><tr><td>\n  Pro-padz\n  Liquid Gel Radiolucent Electrodes used with R, M, E, and X Series\n  Defibrillators\n  <\/td><td>\n  8900-2105-01,\n  8900-2106-01\n  <\/td><td>\n  1719,\n  1719A, 1819\n  <\/td><\/tr><\/tbody><\/table>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Geographic\nRegions: <\/strong>Canada, France, &nbsp;Germany, Italy, &nbsp;U.S.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Manufacturer(s):\n<\/strong>ZOLL Medical Corp269 Mill Rd, Chelmsford, MA 01824-4105, United\nStates<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Suggested\nDistribution: <\/strong>Cardiology\/Cardiac Catheterization Laboratory,\nClinical\/Biomedical Engineering, Critical Care, Emergency\/Outpatient Services,\nNursing, OR\/Surgery, EMS\/Transport, Materials Management<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Problem:<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">In a May 28, 2019, Urgent Device\nCorrection letter submitted by an ECRI Institute member hospital, ZOLL states\nthat the above electrodes used with<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">ZOLL R Series, M Series, E Series, and X Series\ndefibrillators may have been assembled incorrectly, potentially causing the\ndefibrillators to display a &#8220;Check Pads&#8221; or &#8220;Pads Off&#8221;\nmessage and prevent the defibrillator from delivering therapy. ZOLL also states\nthat there is no visual indication to the user on the electrodes that the product\nis not assembled correctly.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Action Needed:<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Identify, isolate, and\ndiscontinue use of any affected product in your inventory. If you have affected\nproduct, verify that you have received the May 28, 2019, Urgent Device\nCorrection letter and Response Form from ZOLL. Complete the Response Form, and\nreturn it to ZOLL. A ZOLL representative will contact your facility to\ncoordinate the return and replacement of affected electrodes. Notify all\nrelevant personnel at your facility of the information in the letter.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>For Further Information:<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">ZOLL technical support department<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Tel.: (800) 348-9011 or (978) 421-9460 Website: <a href=\"https:\/\/www.zoll.com\/contact\">Click here<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Comments:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>This\nalert is a living document and may be updated when ECRI Institute receives\nadditional information.<\/li><\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Source(s):<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>2019 Jun 3. Member Hospital. May 28, 2019, ZOLL\nletter submitted by an ECRI Institute member hospital <a href=\"http:\/\/www.ecri.org\/sites\/alertscontent\/Lists\/SourceDocuments\/Attachments\/194019\/20190528ZollProPadzLiquidGelElectrodesClient_Redacted.pdf\">Download <\/a>\u00e2\u2014\u008f 2019 Jun 3. Manufacturer. The\nmanufacturer has confirmed the information provided in the source material.<\/li><li>2019\nJun 5. BfArM (Germany). 07397\/19 <a href=\"http:\/\/www.ecri.org\/sites\/alertscontent\/Lists\/SourceDocuments\/Attachments\/194021\/20190604ZOLLproPadzBfArM.pdf\">Download<\/a><\/li><li>2019\nJun 5. BfArM (Germany). (includes reply form) <a href=\"http:\/\/www.ecri.org\/sites\/alertscontent\/Lists\/SourceDocuments\/Attachments\/194022\/20190528ZollProPadzElectrodesBfArM.pdf\">Download<\/a><\/li><\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\u00c2\u00a92019 ECRI\nInstitute<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">5200 Butler\nPike, Plymouth Meeting, PA 19462-1298, USA<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">May be\nreproduced by subscribing institution for internal distribution only.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>[High Priority ] &#8211; A32793 : ZOLL\u00e2\u20ac\u201dPro-padz Liquid Gel Radiolucent Electrodes Used with ZOLL R, M, E, and X Series Defibrillators: May Prevent Delivery of Defibrillation or Pacing Therapy [High Priority ] &#8211; A32793 : ZOLL\u00e2\u20ac\u201dPro-padz Liquid Gel Radiolucent Electrodes Used with ZOLL R, M, E, and X Series Defibrillators: May Prevent Delivery of Defibrillation [&hellip;]<\/p>\n","protected":false},"author":8,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-4450","post","type-post","status-publish","format-standard","hentry","category-announcement"],"_links":{"self":[{"href":"https:\/\/midstateems.dreamhosters.com\/blog\/wp-json\/wp\/v2\/posts\/4450","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/midstateems.dreamhosters.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/midstateems.dreamhosters.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/midstateems.dreamhosters.com\/blog\/wp-json\/wp\/v2\/users\/8"}],"replies":[{"embeddable":true,"href":"https:\/\/midstateems.dreamhosters.com\/blog\/wp-json\/wp\/v2\/comments?post=4450"}],"version-history":[{"count":2,"href":"https:\/\/midstateems.dreamhosters.com\/blog\/wp-json\/wp\/v2\/posts\/4450\/revisions"}],"predecessor-version":[{"id":4453,"href":"https:\/\/midstateems.dreamhosters.com\/blog\/wp-json\/wp\/v2\/posts\/4450\/revisions\/4453"}],"wp:attachment":[{"href":"https:\/\/midstateems.dreamhosters.com\/blog\/wp-json\/wp\/v2\/media?parent=4450"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/midstateems.dreamhosters.com\/blog\/wp-json\/wp\/v2\/categories?post=4450"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/midstateems.dreamhosters.com\/blog\/wp-json\/wp\/v2\/tags?post=4450"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}