In a letter dated “June 2019,” the company said the problems could stem from an internal component failure, excess solder during manufacture, physical damage in the field, or the power module reaching the end of its useful life.
If the AC power module fails without a charged battery installed, heart monitoring may be interrupted or shock/pacing therapy delayed, the company said.
Philips has received approximately 100 complaints per year since September 2004. There has been one reported patient death, potentially involving an AC Power Module failure in a device with no battery installed, the company said.
“A charged battery should always be installed in the device as directed in its Instructions for Use, whether or not AC mains power is available at the point of care,” the letter said.
The FDA considers the warning a recall. It is evaluating the manufacturer’s strategy to ensure that public health concerns are addressed and intends to post information online about this action after it classifies the recall, an FDA spokesman told MassDevice in an email.
This is the latest issue for the HeartStart MRx. In December, Philips issued a worldwide recall of the device’s batteries.
The current warning covers devices with model numbers M3535A PRODUCTS M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, and M3536M9.
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