Physio-Control Infant/Child Reduced Energy Defibrillation Electrodes 의 안전성 경고

Safety alert

2017-11-03

2017-11-03

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20171103.html

Medical device safety alert: physio-control infant/child reduced energy defibrillation electrodes the united states food and drug administration (fda) has issued a safety alert concerning a voluntary field action announced by physio-control regarding specific lots of infant/child reduced energy defibrillation electrodes produced by cardinal health. the affected devices are identified as follows:- electrode [catalogue number: 11101-000016; min number: 3202380-006; lot number: 713609, 713904, 715008, 717912, 718033, 719323] electrode starter kits [catalogue number: 11101-000017; min number: 3202784-009 lot number: 45932237, 45979590, 45979954, 46007867, 46023185, 46023823, 46042286, 46050960, 46052545, 46061770, 46063054, 46078012] according to the alert, the artwork on the defibrillation electrodes shows incorrect electrode placement for an infant. there is no issue with the performance or function of the defibrillation electrodes; this is limited to incorrect artwork on the defibrillation electrodes within the packaging. if the user incorrectly places the defibrillation electrodes, it may result in ineffective energy delivery to the patient and serious injury or death. the defibrillation electrodes are used only with lifepak express aed, lifepak cr plus aed, lifepak 1000 defibrillator, or lifepak 500 biphasic aed with a pink connector. adult defibrillation electrodes are not impacted. approximately 14,200 electrodes have been affected. there have been no customer complaints reported for this issue. physio-control is contacting affected users to notify them of the issue, and to provide customers with correct electrode placement instructions to be included with the automated external defibrillators (aeds) until they receive their corrected defibrillation electrodes. physio-control will provide replacement products for all unused affected defibrillation electrodes. according to the local supplier, the affected products are distributed in hong kong. for details, please refer to the fda website: https://www.Fda.Gov/safety/recalls/ucm583529.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 3 november 2017.