HeartStart MRX Monitor/Defibrillator

• • Terminated Z-0278-2018 FDA Class II ·initiated 28 Sep 2017 ·on shared 510(k) K062233

  Philips MRx devices have an EtCO2 module that may contain contamination; this contamination (will/may) cause the device to be unable to display the EtCO2 or CO2 waveform (capnogram).

• • Terminated Z-0348-2018 FDA Class II ·initiated 17 Jul 2017

  Issue with ECG out cables. When a Philips monitor/defibrillator is receiving an ECG signal from an auxiliary bedside monitor via a sync cable or ECG out cable, the following can occur if the monitor/defibrillator experiences interference from electrical fast transients (EFTs): " On the HeartStart MRx and HeartStart XL, EFT noise may be misinterpreted as an R-wave. " On the HeartStart XL+, EFT noise can disable ECG monitoring and potentially interrupt demand mode pacing*. *Note: It is contrary to the XL+ Instructions for Use to perform demand mode pacing while using the ECG out cable or obtaining the ECG signal from a bedside monitor. The XL+ Instructions for Use includes the following warning: When pacing in Demand Mode, the ECG cable from the patient must be directly connected to the HeartStart XL+. If the user follows this warning, this problem cannot occur on the XL+.

• • Terminated Z-0489-2018 FDA Class I ·initiated 12 Jul 2017

  Affected units may have a defective component that is intended to protect the internal circuitry from high voltages during shock delivery. The defective component may also prevent delivery of shocks in AED mode.

• • Terminated Z-1417-2017 FDA Class I ·initiated 24 Feb 2017

  HeartStart MRx Monitor/Defibrillator may may exhibit abnormal behavior when operating using a single battery as the sole source of power may fail to deliver therapy or monitoring

• • Terminated Z-2842-2016 FDA Class II ·initiated 26 Aug 2016

  The handle can separate from the MRx housing due to breakage of mounts on the rear case.

• • Terminated Z-1612-2016 FDA Class II ·initiated 14 Apr 2016

  MRx monitor/defibrillators could fail to charge because the therapy printed circuit board may have been loaded with an incorrect electronic component.

• • Terminated Z-0320-2016 FDA Class II ·initiated 14 Oct 2015

  The following MRx software issue has been identified: MRx model M3535A with software version F.03.06 and earlier, and model M3536A with version T.00.05 and earlier may stop the automated Ready-For-Use (RFU) test in an abnormal state when the device is turned off.

• • Terminated Z-0219-2016 FDA Class II ·initiated 23 Dec 2014

  MRx monitor/defibrillator could reboot at an indeterminate time, potentially causing therapy to be interrupted or delayed

• • Terminated Z-0963-2015 FDA Class II ·initiated 19 Nov 2014

  Device may malfunction, which could cause therapy to be delayed, disabled, or delivered inadvertently.

• • Terminated Z-0204-2016 FDA Class II ·initiated 19 Nov 2014

  1. Device will perform the weekly automated tests hourly, which could cause the therapy capacitors to degrade sooner than intended and 2. While connected to AC or DC power and with no battery installed or the battery installed has a charge level of less than 10%, the Ready for Use (RFU) indicator will not provide the expected low battery indication

• • Terminated Z-0262-2016 FDA Class II ·initiated 19 Nov 2014

  MRx Defib can be susceptible to one or both issues: 1. The C02 Inlet Port associated with end-tidal carbon dioxide (EtCO2) monitoring on MRx Monitor/Defibrillators can be pushed into the MRx housing, making it inaccessible. 2. The handle can separate from the MRx housing due to breakage of mounts on the rear case.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K062233 ↗

FDA Product Code

MKJ

Device Class

Class III

Regulation

21 CFR Part 870.5310

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Philips Medical Systems North America, Inc. →

• What types of cardiac events can the HeartStart MRX help diagnose and treat, and how does it do so?

  The HeartStart MRX Monitor/Defibrillator is designed to diagnose and treat cardiac arrhythmias by delivering synchronized cardioversion and defibrillation. It includes advanced real-time ECG analysis, including 12-lead ECG capabilities via the DXL algorithm, which aids in rapidly identifying issues like ventricular fibrillation, ventricular tachycardia, and other life-threatening arrhythmias. This helps guide resuscitation efforts by providing immediate insights into the patient’s heart rhythm.

• Is the HeartStart MRX suitable for use in MRI environments, and if not, what precautions should be taken?

  No, the HeartStart MRX is explicitly not MRI-compatible and must only be used in non-MRI environments. Since it is a reusable medical device, it should be kept away from MRI machines to avoid interference or damage to either the device or the imaging system. Always follow manufacturer guidelines for storage and handling to ensure safe operation.

• How is the HeartStart MRX supplied, and what maintenance or cleaning procedures are required?

  The HeartStart MRX is supplied as a reusable medical device, meaning it is designed for repeated use in clinical settings. After each use, it must undergo proper cleaning and maintenance as outlined by Philips Medical Systems to ensure sterility, functionality, and safety. Standard protocols for reusable defibrillators apply, including disinfection and routine servicing to comply with regulatory and infection-control standards.

• What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use?

  The HeartStart MRX received FDA clearance through the Special 510(k) pathway, which was granted on November 22, 2006. This pathway was used because the device was determined to be substantially equivalent to a legally marketed predicate device. This clearance confirms that the HeartStart MRX meets FDA safety and effectiveness standards for use as an Automated External Defibrillator (Non-Wearable) in emergency care settings, including pre-hospital and in-hospital environments.