Lifepak 20 Defibrillator/ Monitor

• 2 recalls, same reason

  • Terminated Z-2010-2008 FDA Unclassified (pre-2012) ·initiated 13 May 2008 ·on shared 510(k) K063119
  • Terminated Z-2011-2008 FDA Unclassified (pre-2012) ·initiated 13 May 2008 ·on shared 510(k) K063119

  A thicker keypad that may prevent the door from fully latching closed. If the door is not fully closed, there is a potential that the defibrillator will not automatically change from automatic external defibrillation (AED) mode to manual mode by pressing the "MANUAL" button located on the lower left corner of the door. This may lead to a delay in defibrillation therapy.

• • Terminated Z-2009-2008 FDA Unclassified (pre-2012) ·initiated 13 May 2008 ·on shared 510(k) K063119

  A thicker keypad may prevent the door from fully latching closed. If the door is not fully closed, there is a potential that the defibrillator will not automatically change from automatic external defibrillation (AED) mode to manual mode by pressing the "MANUAL" button located on the lower left corner of the door. This may lead to a delay in defibrillation therapy.

• • Terminated Z-1906-2008 FDA Unclassified (pre-2012) ·initiated 16 Apr 2008 ·on shared 510(k) K063119

  The LIFEPAK 20e defibrillator / monitors with software versions 058 have an increase in likelihood for an incorrect Shock Advisory Algorithm (SAS) decision if the Auto Analyze setting in AED mode is On, leading to incorrectly render of shock or no shock decision. When Auto Analyze is set to On in AED mode the device initiates the SAS analysis immediately (no waiting period or warning prior to anal

• • Terminated Z-1905-2008 FDA Unclassified (pre-2012) ·initiated 16 Apr 2008 ·on shared 510(k) K063119

  The LIFEPAK 20 defibrillator / monitors with software versions 048, 052 and 054 have an increase in likelihood for an incorrect Shock Advisory Algorithm (SAS) decision if the Auto Analyze setting in AED mode is On, leading to incorrectly render of shock or no shock decision. When Auto Analyze is set to On in AED mode the device initiates the SAS analysis immediately (no waiting period or warning p

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

510(k) Number

K063119 ↗

FDA Product Code

MKJ

Device Class

Class III

Regulation

21 CFR Part 870.5310

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• LifePak 12 Defibrillator/Monitor

  Class III

  FDA 510(k) K063510 Active Cleared 26 Jan 2007

• Lifenet Exchange System

  Class II

  FDA 510(k) K052854 Active Cleared 20 Jan 2006

• LifePak 1000

  Class III

  FDA 510(k) K042404 Active Cleared 22 Dec 2005

• LifePak 500 Automated External Defibrillator

  Class III

  FDA 510(k) K052057 Active Cleared 17 Feb 2006

• LifePak 12 Defibrillator/Monitor

  Class III

  FDA 510(k) K041459 Active Cleared 1 Jul 2004

• Is the LifePak 20 Defibrillator/Monitor designed for single-use or reusable applications in emergency settings?

  The LifePak 20 Defibrillator/Monitor is explicitly described as a reusable medical instrument, intended for use in both clinical and pre-hospital emergency environments. Since it is reusable, it requires proper maintenance, cleaning, and storage as outlined by the manufacturer to ensure functionality and safety for repeated use.

• What types of environments is the LifePak 20 Defibrillator/Monitor intended for, and does it require special handling?

  The device is designed for clinical and pre-hospital emergency settings, where cardiac arrest patients may require defibrillation. It is not MRI-safe, meaning it cannot be used near MRI machines, and must be stored according to manufacturer guidelines to maintain functionality and sterility. Proper training is also required for operation.

• How is the regulatory status of the LifePak 20 Defibrillator/Monitor determined, and what oversight applies?

  The device holds FDA 510(k) clearance under classification III, with regulatory oversight governed by regulation number 870.5310. It was reviewed by the Cardiovascular (CV) Advisory Committee and classified as substantially equivalent to a predicate device. The clearance type is noted as Special, indicating a thorough evaluation process.

• Does the LifePak 20 Defibrillator/Monitor include real-time monitoring capabilities, and how does it guide resuscitation efforts?

  Yes, the LifePak 20 combines defibrillation with real-time cardiac monitoring to assess heart rhythms. It operates in both manual and semi-automated modes, providing guidance for resuscitation efforts by analyzing the patient’s rhythm and advising appropriate actions during cardiac arrest.