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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
510K
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.
Clinical Applications
This device is commonly used in home settings for individuals at risk of sudden cardiac arrest, such as those with a history of heart disease. It is also suitable for use in community settings, such as schools and sports facilities, where trained laypersons may need to respond to cardiac emergencies. The device is particularly valuable in rural or remote areas where immediate medical assistance may not be readily available.
Indications for Use
The FDA indications for the Philips HeartStart Home Defibrillator include its use in treating sudden cardiac arrest in adults and children over 8 years old or weighing more than 55 pounds. It is intended for use by laypersons who have received basic training in its operation.
Practical Considerations
The Philips HeartStart Home Defibrillator is designed to be user-friendly, with clear voice prompts and visual cues. It is compatible with standard AED pads and requires regular maintenance checks to ensure readiness. The device is portable and lightweight, making it easy to store and transport.
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)
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Onyx Liquid Embolic Agent: Basic Knowledge for Its Use in Interventional Neuroradiology.
Journal of neuroendovascular therapy
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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
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PubMed • 2025
Clinical progress note: Haemophilus influenzae type b.
Journal of hospital medicine
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PubMed • 2025
Pilot study of social media promotion of home-based self-testing for syphilis.
Sexually transmitted diseases
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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
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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
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PubMed • 2025
Palm Multidiagnostic of Mycoplasma pneumoniae, Chlamydia pneumoniae, Haemophilus influenzae, and Streptococcus pneumoniae Using One-Tube CRISPR/Cas12a.
Transboundary and emerging diseases
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PubMed • 2025
Tp40: a new potential prognostic and diagnostic marker for syphilis.
Microbiology spectrum
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PubMed • 2025
Serotonin sets up neutrophil extracellular traps to promote neuroendocrine prostate cancer metastasis in the liver.
The Journal of clinical investigation
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PubMed • 2025
Application value of Philips Ingenuity TF PET/CT scanner imaging agent FAP in evaluating renal fibrosis.
Hellenic journal of nuclear medicine
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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
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PubMed • 2025
Improved patient comfort and procedural efficiency using chlorhexidine-coated hydrophilic urethral catheters: a randomized controlled trial.
Journal of Yeungnam medical science
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PubMed • 2025
pTx-Pulseq in hybrid sequences: Accessible and advanced hybrid open-source MRI sequences on Philips scanners.
Magnetic resonance in medicine
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PubMed • 2025
Comparative connectomics of Drosophila descending and ascending neurons.
Nature
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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.