The Amsterdam-based company said in the notice that it received reports of HeartStart MRx devices that suffered internal damage and could not deliver therapy after they were dropped or subjected to a severe mechanical shock. The damage and/or inability to deliver therapy occurred even though there was no external damage visible and the “Ready for Use” indicator on the unit did not immediately indicate an issue.
Philips received one report involving the death of a user after an MRx that may have been damaged in the described way failed. However, the user concluded that the failure of the device did not contribute to the inability to resuscitate the patient.
HeartStart MRx is designed to perform automatic, periodic self-tests that can detect such damage, along with regularly scheduled manual operational checks recommended in the product’s instructions. The alerts come in the form of the RFU indicator and an audible chirp.
However, if the device is needed for therapeutic use before the next automatic self-test or manual operational check, Philips said the user should perform an operational check after a device is dropped, subjected to a mechanical shock or otherwise mishandled.
Philips told users to take the unit out of service and contact Philips customer service if it is visibly damaged or if the device fails on the operational check. Failure could consist of the RFU indicator changing to a red “X” or the audible chirp. The company intends to insert a copy of its warning notice with each unit of the device in the future.