Covidien Defibrillation Electrodes Warning Issued After Patient Death
Medical device manufacturer Covidien has issued a field safety alert for two types of defibrillation electrodes, following reports that suggests a patient may have died because they were not compatible with other equipment.
Covidien issued the Medi-Trace Cadence and Kendall Multi-function defibrillation electrodes field warning on October 10, which the FDA has categorized as a Class I medical device recall.
According to the manufacturer, the electrodes will not connect with Philips FR3 or FRx Automated External Defibrillators (AEDs). If use is attempted with the FR3 in particular, it could result in a delay in treatment or death.
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The manufacturer has received at least two reports involving problems with the defibrillation electrodes, including at least one case where a delay in treatment may have caused a patient to die.
The alert affects 644,460 electrodes, including the Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes Radiotransparent and Pre-Connect, Kendall Adult Multi-Function Defibrillation Electrodes, Kendall 1710H Multi-Function Defibrillation Electrodes, the MedChoice Multifunction Electrode, and the Philips HEARTSTART Multifunction Electrode Pads. All lot numbers are affected.
Covidien is asking customers to review the use of the defibrillation electrodes in their facility to make certain that the Covidien electrodes are not placed for use with Philips model FR3 or FRx AEDs. Customers were notified of the problem in September, and the company has revised the electrodes’ labeling.
The FDA Class 1 designation means that the agency considers the safety warning to be the most serious category of recall, suggesting that continued use of the device poses a reasonable risk of serious injury or death.
Customers with questions can contact Covidien Quality Assurance at (800) 962-9888, option 8, extension 2500 or email Mansfield.productmonitoring@Covidien.com.
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