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Philips Heartstart Home Defibrillator Model M5068A
Philips Medical Systems
Summary: The Philips HeartStart Home Defibrillator is an automated external defibrillator (AED) designed for home use by laypersons. It's used to treat sudden cardiac arrest by delivering a shock to restore normal heart rhythm.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K040904 ↗
Decision Date ?
September 16, 2004
Product Code ?
NSA
Device Class ?
Class 3
Evidence ?
419 studies
The Philips HeartStart Home Defibrillator, manufactured by Philips Medical Systems, was cleared via the FDA 510(k) pathway on September 16, 2004. It is a Class III medical device under product code NSA.
What It Is
The Philips HeartStart Home Defibrillator is an automated external defibrillator designed for use in home settings. It is intended to be used by laypersons with minimal training to provide emergency treatment for sudden cardiac arrest. The device analyzes the heart's rhythm and, if necessary, delivers an electrical shock to help restore a normal rhythm. It features voice prompts and visual instructions to guide the user through the process.
FDA-Cleared Indications
- Treatment of suspected sudden cardiac arrest in adults.
- Treatment of suspected sudden cardiac arrest in children older than 8 years or weighing more than 55 pounds.
- Use by laypersons who have received basic training in AED operation.
Clinical Applications
- Emergency defibrillation for an unresponsive person who is not breathing normally and may be in sudden cardiac arrest.
- Rhythm analysis to determine whether a defibrillation shock is appropriate.
- Layperson response to sudden cardiac arrest in a home setting.
- Emergency response in community settings where the device is available and the operator is trained.
Practical Considerations
- The device is intended for external use with adhesive defibrillation pads placed on the bare chest; follow the device prompts and pad instructions.
- The labeling described here applies to adults and children older than 8 years or weighing more than 55 pounds; pediatric use and pediatric pads should follow the specific device labeling.
- Do not touch the patient while the AED is analyzing the rhythm or delivering a shock, and do not use it in a wet environment unless the chest is dried and the device instructions are followed.
- This is not an MRI-safe device and should not be brought into the MRI scanner room or near the magnetic field.
- Check pad expiration, battery status, physical condition, and readiness indicators according to the manufacturer’s instructions. AED pads and batteries are replaceable consumables.
Related Literature
The linked study, 'HeartStart HS1 Defibrillator Event Registry,' aimed to collect data on the use and outcomes of the HeartStart HS1 Defibrillator in real-world settings. Although specific details and findings are not available, such registries typically assess device performance, user compliance, and patient outcomes. Limitations may include the lack of detailed clinical data and variability in user training and experience.
Linked Studies (20)
PubMed • 2025
Onyx Liquid Embolic Agent: Basic Knowledge for Its Use in Interventional Neuroradiology.
Journal of neuroendovascular therapy
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Performance evaluation of quantitative hemoglobin A2 and fetal hemoglobin testing using commercially lyophilized vs. in-house whole blood controls in Chinese clinical laboratories: a 12-year analysis of National External Quality Assessment Data.
Clinical chemistry and laboratory medicine
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Clinical progress note: Haemophilus influenzae type b.
Journal of hospital medicine
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Pilot study of social media promotion of home-based self-testing for syphilis.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Clinical development and performance of the First to Know Syphilis Self-Test for over-the-counter usage: a de novo rapid test for treponemal antibody.
Journal of clinical microbiology
View Source →PubMed • 2025
Implementation of an Opt-Out and Rapid Point-of-Care Syphilis Testing Program for Pregnant Patients Presenting to the Emergency Department.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Evaluation of Rapid Syphilis Testing Using the Syphilis Health Check in Florida, 2015-2016.
Florida public health review
View Source →PubMed • 2025
Multiplex droplet digital PCR for the detection and quantitation of Streptococcus pneumoniae, Mycoplasma pneumoniae, and Haemophilus influenzae.
Frontiers in cellular and infection microbiology
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Palm Multidiagnostic of Mycoplasma pneumoniae, Chlamydia pneumoniae, Haemophilus influenzae, and Streptococcus pneumoniae Using One-Tube CRISPR/Cas12a.
Transboundary and emerging diseases
View Source →PubMed • 2025
Tp40: a new potential prognostic and diagnostic marker for syphilis.
Microbiology spectrum
View Source →PubMed • 2025
Serotonin sets up neutrophil extracellular traps to promote neuroendocrine prostate cancer metastasis in the liver.
The Journal of clinical investigation
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Application value of Philips Ingenuity TF PET/CT scanner imaging agent FAP in evaluating renal fibrosis.
Hellenic journal of nuclear medicine
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Message from Dr. Philippe T. Georgel, Guest Editor for the Marshall University Collection, Brad D. Smith, President of Marshall University, and Dr. Anivandan Mukherjee, Provost of Marshall University.
Biochemistry and cell biology = Biochimie et biologie cellulaire
View Source →PubMed • 2025
Improved patient comfort and procedural efficiency using chlorhexidine-coated hydrophilic urethral catheters: a randomized controlled trial.
Journal of Yeungnam medical science
RCT View Source →PubMed • 2025
pTx-Pulseq in hybrid sequences: Accessible and advanced hybrid open-source MRI sequences on Philips scanners.
Magnetic resonance in medicine
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Comparative connectomics of Drosophila descending and ascending neurons.
Nature
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Hydrophilic-coated sheaths for reducing radial artery spasm during transradial procedures: A systematic review and meta-analysis.
Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences
View Source →PubMed • 2025
History of antineutrophil cytoplasmic autoantibodies : Milestones in rheumatology.
Zeitschrift fur Rheumatologie
View Source →PubMed • 2025
A Hydrophilic Polyurethane Foam Containing Nigella sativa Oil as a Wound Dressing.
BioMed research international
RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What is the Philips HeartStart Home Defibrillator used for?
It is used to treat sudden cardiac arrest by delivering an electrical shock to restore normal heart rhythm.
What specialties typically use this device?
While primarily designed for laypersons, it is also used by emergency responders and in community health settings.
What are the FDA-cleared indications?
It is indicated for treating sudden cardiac arrest in adults and children over 8 years old or weighing more than 55 pounds.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.