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Modification to Philips M3000A M3046A Compact Portable Patient Monitor Models Philips M3000A M3046A
Philips Medical Systems
Summary: The Philips M3000A M3046A is a compact portable patient monitor used to track vital signs in various clinical settings. It's primarily used by healthcare professionals in hospitals and clinics.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K013427 ↗
Decision Date ?
November 29, 2001
Product Code ?
MHX
Device Class ?
Class 2
Evidence ?
419 studies
This device was cleared through the FDA 510k pathway on November 29, 2001, by Philips Medical Systems. It is classified as a Class 2 device under product code MHX.
What It Is
The Philips M3000A M3046A is a portable patient monitor designed to provide continuous monitoring of vital signs such as heart rate, blood pressure, and oxygen saturation. Its compact design allows for easy transport and use in various clinical environments, making it ideal for both bedside and mobile monitoring. The device integrates with other hospital systems for comprehensive patient management.
FDA-Cleared Indications
- Monitoring physiologic parameters in patients who require observation in a healthcare setting.
- Displaying vital-sign measurements using compatible monitoring modules, sensors, and accessories.
- Supporting monitoring at the bedside or during movement within a healthcare facility.
Clinical Applications
- Monitoring patients in hospital departments where portable vital-sign assessment is needed.
- Monitoring patients during transport within a healthcare facility.
- Displaying measurements from compatible physiologic sensors and monitoring modules.
- Supporting clinical observation when used by trained healthcare professionals according to the device labeling.
Practical Considerations
- The available measurements depend on the specific M3000A/M3046A configuration, installed modules, cables, sensors, and accessories.
- Use only compatible, maintained accessories and verify alarm limits and sensor placement before monitoring.
- The monitor is not a substitute for clinical assessment or treatment of an unstable patient.
- Confirm electromagnetic-compatibility requirements and facility electrical-safety procedures before use.
- MRI compatibility should not be assumed; the monitor and its accessories should be removed from the MRI environment unless the specific labeling identifies them as MR Safe or MR Conditional.
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 M3000A M3046A used for?
It is used for continuous monitoring of vital signs in patients across various clinical settings, including emergency, intensive care, and during transport.
What specialties typically use this device?
Emergency medicine, critical care, anesthesiology, and transport teams frequently use this device for patient monitoring.
What are the FDA-cleared indications?
The device is indicated for monitoring vital signs in patients requiring continuous observation, particularly those with cardiovascular or respiratory conditions.
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.