It was reported to philips that a patient in atrial fibrillation and respiratory failure died while being treated with the heartstart mrx defibrillator.The user was attempting to perform synchronized cardioversion but mistakenly did not press the ¿sync¿ button and instead a defibrillation shock was unintentionally administered to the patient.Philips brand defibrillator pads were being used.The patient received 150j and 200j shock.The patient died.The customer biomed contacted the philips response center.The customer biomed was informed that service could no longer be completed on the unit as the device had reached end of life (eol).The heartstart mrx device and all associated service/support was discontinued on (b)(6) 2022.The customer biomed stated that the involved defibrillator pads were discarded.The customer biomed was advised to print the autotest and status logs and performed simulator tests.The device passed all performance assurance tests.The sync button was tested multiple times with the defib analyzer and no issues were found.A philips clinician evaluated the provided patient event file.At elapsed time (et) 00:00:01, pads were placed on patient and device was in monitor mode.There was artifact present in ecg signal throughout case (can be caused by patient movement, pad placement or poor pad adherence).At et 00:00:24, monitor learning cardiac rhythm.Presenting cardiac rhythm is atrial fibrillation.At et 00:00:30, hr 151bpm, atrial fibrillation rhythm, at et 00:00:54, energy selected at 150j.At et 00:01:12, shock 1 delivered ¿ asynchronous ¿ sync mode was not engaged.At et 00:05:31, hr 139bpm, atrial fibrillation rhythm.At et 00:10:18, energy selected at 200j.At et 00:10:32, hr 139bpm.At et 00:10:50, shock 2 delivered ¿ asynchronous ¿ sync mode was not engaged.At et 00:10:50, cardiac rhythm is ventricular fibrillation.At et 00:13:12, vfib/vtach alarm.At et 00:13:14, device off.Synchronized defibrillation shocks are delivered in manual defibrillation mode, when the ¿sync¿ button is engaged and energy is selected.The sync button was not engaged prior to either shock.Each shock was delivered asynchronously.The second shock converted the atrial fibrillation to ventricular fibrillation.Asynchronous defibrillation shocks applied to a perfusing rhythm has the potential to induce ventricular fibrillation, which did occur in this case.The device performed as expected.The investigation confirmed the user did not press the sync button.The device remains with the customer.
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