Jump Start, Model 970300

• • Terminated Z-1656-2009 FDA Unclassified (pre-2012) ·initiated 24 Apr 2009

  Possible for users to misunderstand signals. The original product labeling told users that a flashing low battery indicator signals that the battery is low and requires changing soon. If a user experiences a flashing low battery status indicator and does not understand that the device can continue to be used, the user might choose not to continue operating the device, thereby causing therapy to

• • Terminated Z-1389-2009 FDA Unclassified (pre-2012) ·initiated 26 Feb 2009

  Issue #1: AED 10 displayed a "Do Not Use" symbol as a result of a blown F1 fuse. Issue #2: AED 10 models that incorporate a spring connector with the speaker experienced intermittent electrical connection to the circuit board causing a loss of voice prompts.

• • Terminated Z-1007-2009 FDA Unclassified (pre-2012) ·initiated 15 Dec 2008

  Potential for device to deliver less than the programmed energy.

• • Terminated Z-1006-2009 FDA Unclassified (pre-2012) ·initiated 15 Dec 2008

  Reliability issues - potential to shock a non shockable rhythm or not shocking a shockable rhythm;

• • Terminated Z-1005-2009 FDA Unclassified (pre-2012) ·initiated 15 Dec 2008

  Potential for device to shut down prematurely under certain circumstances.

• • Terminated Z-0129-2008 FDA Unclassified (pre-2012) ·initiated 26 Oct 2007

  Failure to Deliver Shock; a defective capacitor may cause the delay or non-delivery of the defibrillating shock which may result in failure to resuscitate the patient

• • Terminated Z-0918-04 FDA Unclassified (pre-2012) ·initiated 26 Apr 2004 ·on shared 510(k) K021168

  A faulty component has been identified which could result in an intermittent shock button (button #3) failure on the AED10 defibrillator.

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

510(k) Number

K021168 ↗

FDA Product Code

MKJ

Device Class

Class III

Regulation

21 CFR Part 870.5310

Advisory Committee

Cardiovascular

FDA Decision

ST

• Porta Pak 90

  Class II

  FDA 510(k) K840900 Active Cleared 11 Jun 1984

• Dpd Defibrillator

  Class II

  FDA 510(k) K952085 Active Cleared 5 Jun 1995

• Porta Pulse III #D320

  Class II

  FDA 510(k) K833751 Active Cleared 11 Jan 1984

• Portable Intensive Care Unit Modification

  Class III

  FDA 510(k) K983307 Active Cleared 20 Nov 1998

• Mrl Blood Pressure Monitor

  Class II

  FDA 510(k) K885191 Active Cleared 23 May 1989

• 450SLL Defibrillator

  Class II

  FDA 510(k) K874204 Active Cleared 28 Jan 1988

See all devices from Medical Research Laboratories, Inc. →

• What types of life-threatening heart rhythms is the Jump Start Model 970300 designed to treat?

  The Jump Start Model 970300 is specifically designed to deliver electrical shocks to restore normal heart rhythm in patients experiencing sudden cardiac arrest due to life-threatening arrhythmias such as ventricular fibrillation or pulseless ventricular tachycardia. It is intended for use by trained personnel in emergency settings to provide immediate intervention.

• Is the Jump Start Model 970300 a single-use or reusable device?

  The Jump Start Model 970300 is a reusable medical device. It is not intended for single-use and must be maintained and stored according to the manufacturer’s guidelines to ensure proper functionality for repeated emergency use.

• What regulatory pathway was followed for FDA clearance of this device?

  The Jump Start Model 970300 received FDA clearance through a 510(k) submission (K021168) under the Traditional 510(k) Review pathway, with a decision of Substantially Equivalent (ST) and subject to tracking. It falls under FDA regulation 870.5310 and is classified as an Automated External Defibrillator (Non-Wearable) with product code MKJ.

• Can this device be used in an MRI environment?

  No, the Jump Start Model 970300 is not indicated for MRI use. It must be stored and operated in non-MRI environments to avoid interference or safety risks.

• What settings is this device approved for use in?

  The Jump Start Model 970300 is intended for use in clinical and pre-hospital emergency settings, such as hospitals, ambulances, and other locations where trained personnel may respond to sudden cardiac arrest. It is not approved for home use or non-emergency settings.