MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HEARTSTART MRX MONITOR/DEFIB; DEFIBRILLATOR

Model Number M3535A

Device Problem Unintended Electrical Shock (4018)

Patient Problems Atrial Fibrillation (1729); Respiratory Failure (2484)

Event Date 08/21/2022

Event Type  Death  

Event Description

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.

Manufacturer Narrative

The customer biomed contacted the philips response center.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.The customer evaluated the device.

• Brand Name: HEARTSTART MRX MONITOR/DEFIB
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer Contact: laura scanlan ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 15770892
• MDR Text Key: 303414858
• Report Number: 3030677-2022-05029
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838000018
• UDI-Public: (01)00884838000018
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K031187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M3535A
• Device Catalogue Number: 861288
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death