Zoll E Series Defibrillator

• • Terminated Z-2294-2011 FDA Unclassified (pre-2012) ·initiated 21 Apr 2011

  Zoll E Series BLS Defibrillator may fail to auto charge and deliver energy

• • Terminated Z-1547-2010 FDA Unclassified (pre-2012) ·initiated 24 Mar 2010

  Device issued Shock Advised message but failed to auto-charge the defibrillator.

• • Terminated Z-1167-2008 FDA Unclassified (pre-2012) ·initiated 15 Jan 2008

  Incorrect Patient Records: Patient records that have been stored, then later transmitted or printed may not be the correct record. Records that are transmitted or printed immediately following acquisition are correct.

510(k) Number

K042007 ↗

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 Zoll Medical Corporation →

• Is the Zoll E Series Defibrillator suitable for use in public access programs, and if so, what training is required for operators?

  Yes, the Zoll E Series Defibrillator is explicitly designed for public access settings alongside pre-hospital and hospital use. Since it is intended for trained responders, operators must complete certification in cardiopulmonary resuscitation (CPR) and automated external defibrillator (AED) use, as outlined in the manufacturer’s operator’s manual. The device provides voice prompts to guide users through resuscitation procedures, including defibrillation, pacing, and CPR feedback, which helps ensure proper operation even for trained but inexperienced responders.

• How is the Zoll E Series Defibrillator maintained, and what are the key considerations for its long-term operational integrity?

  The Zoll E Series Defibrillator is a reusable device, so it requires regular calibration and maintenance as specified in the operator’s manual to ensure reliability. Proper storage is also critical—it must be kept in accordance with manufacturer guidelines to preserve functionality. Unlike single-use devices, this model demands periodic servicing to maintain accuracy in rhythm analysis and shock delivery, which is essential for its performance in life-threatening cardiac arrest scenarios.

• Can the Zoll E Series Defibrillator be used near MRI equipment, and what precautions should be taken if it is stored in a facility with MRI capabilities?

  No, the Zoll E Series Defibrillator is explicitly not MRI-safe, meaning it should never be used or stored in proximity to MRI equipment. The device’s electronic components and battery systems could be compromised by magnetic fields, risking malfunction during critical use. If stored in an MRI facility, it must be kept in a designated non-MRI area, following the manufacturer’s storage guidelines to prevent exposure to magnetic interference.

• What distinguishes the Zoll E Series Defibrillator’s algorithm from other automated external defibrillators, particularly in terms of user guidance?

  The Zoll E Series Defibrillator incorporates advanced algorithms that analyze heart rhythms in real time and provide voice prompts for resuscitation procedures, including defibrillation, pacing, and CPR feedback. This feature distinguishes it by offering step-by-step guidance to trained responders, even in high-stress situations, ensuring adherence to evidence-based protocols for restoring normal heart rhythm during sudden cardiac arrest.