đź“Š Evidence-Based Reference
m3810a philips telemonitoring system with edevice bridged130
Lifeline Systems
Summary: The m3810a Philips Telemonitoring System is a device for remote patient monitoring, primarily used in managing home noninvasive ventilation. Key evidence highlights its role in identifying inadequate ventilation.
FDA Clearance Information
Pathway
510K
Number
K103214 ↗
Decision Date
December 1, 2010
Product Code
DRG
Device Class
Class 2
Evidence
419 studies
The m3810a Philips Telemonitoring System was cleared by the FDA via the 510(k) pathway on December 1, 2010. Manufactured by Lifeline Systems, it is classified as a Class 2 device under product code DRG.
What It Is
The m3810a Philips Telemonitoring System is a telemonitoring device designed for remote monitoring of patients, particularly those requiring home noninvasive ventilation. It facilitates the management of patient care by providing real-time data to clinicians.
Clinical Applications
This device is commonly used in scenarios requiring continuous monitoring of patients with respiratory conditions, such as those on home noninvasive ventilation. It aids in timely intervention by alerting clinicians to changes in patient status.
Evidence Summary
The available literature includes 10 studies, with a mix of RCTs, prospective, and retrospective studies. The studies span from 2023 to 2025, focusing on the device's efficacy in telemonitoring and patient management.
Reported Outcomes
Published studies report that the m3810a Philips Telemonitoring System effectively identifies patients with inadequate ventilation, potentially reducing healthcare costs. It also supports adherence to treatment protocols in various clinical settings.
Safety Profile
Reported complications include technical issues related to data transmission and occasional false alerts. However, no significant adverse events directly attributed to the device were noted in the studies.
Evidence Limitations
Current evidence is limited by the small number of studies directly evaluating the device's long-term impact on patient outcomes. Further research is needed to explore its effectiveness across diverse patient populations.
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 are the clinical indications for m3810a Philips Telemonitoring System?
The device is indicated for remote monitoring of patients, particularly those requiring home noninvasive ventilation.
What outcomes have been reported in clinical studies?
Studies report effective identification of inadequate ventilation and support for treatment adherence.
What complications have been reported?
Safety data indicate technical issues with data transmission and false alerts, but no significant adverse events.
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.