đź“Š Evidence-Based Reference
Philips Intellivue Guardiansoftware
Philips Medizin Systeme Boblingen
Summary: Philips IntelliVue GuardianSoftware is a patient monitoring system designed for continuous monitoring of vital signs. It is primarily used in hospital settings to detect and alert clinicians to potential cardiac arrhythmias. Key evidence highlights its usability and performance in detecting ventricular arrhythmias.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K151736 ↗
Decision Date ?
October 21, 2015
Product Code ?
DXJ
Device Class ?
Class 2
Evidence ?
419 studies
The Philips IntelliVue GuardianSoftware was cleared through the FDA 510(k) pathway on October 21, 2015. It is manufactured by Philips Medizin Systeme Boblingen and classified as a Class 2 device under product code DXJ.
What It Is
The Philips IntelliVue GuardianSoftware is a clinical device designed for continuous monitoring of patient vital signs, including heart rate and respiratory rate. It is intended for use in hospital settings to enhance patient safety by providing early detection of potential adverse events.
FDA-Cleared Indications
- Continuous monitoring of patients' vital signs in a hospital environment.
- Monitoring may include parameters such as heart rate and respiratory rate when connected to compatible monitoring devices.
- Detection and notification of potentially significant physiologic changes, including cardiac rhythm abnormalities.
Clinical Applications
- Continuous vital-sign monitoring in hospitalized patients.
- Monitoring patients who require ongoing observation for changes in heart rate or respiratory rate.
- Use in critical-care and other hospital settings where physiologic monitoring and clinician notification are needed.
- Supporting clinical review of monitored data and alerts for possible cardiac rhythm abnormalities.
Evidence Summary
The available literature includes 10 studies, comprising various study types such as observational cohort studies and usability evaluations. The studies span from 2021 to 2025, providing insights into the device's performance and usability in clinical settings.
Reported Outcomes
Published studies report that the Philips IntelliVue GuardianSoftware effectively detects ventricular cardiac arrhythmias and reduces alarm fatigue by minimizing false alarms. Usability studies highlight its user-friendly interface, which is preferred by clinical staff in critical care units.
Safety Profile
Reported complications include concerns about alarm fatigue due to high false alarm rates, which can impact clinical decision-making. However, the device's design improvements aim to address these issues by enhancing alarm accuracy.
Evidence Limitations
The evidence is limited by the lack of large-scale randomized controlled trials directly assessing clinical outcomes. Further research is needed to evaluate long-term patient outcomes and the impact of the device on clinical workflow efficiency.
Practical Considerations
- This is software used as part of a compatible patient-monitoring system; performance depends on the connected monitors, sensors, network, and hospital configuration.
- It is intended to support, not replace, direct clinical assessment and clinician interpretation of alarms and monitored data.
- The software does not itself make a definitive diagnosis of an arrhythmia or determine treatment.
- MRI compatibility is determined by the complete monitoring system, connected hardware, cables, sensors, and the specific MRI environment; confirm the applicable Philips labeling before use near an MRI scanner.
- Alarm settings, connectivity, data display, and clinical workflow require facility configuration and appropriate staff training.
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 Philips IntelliVue GuardianSoftware?
The device is indicated for continuous monitoring of vital signs in hospital settings, particularly for detecting cardiac arrhythmias in critical care environments.
What outcomes have been reported in clinical studies?
Studies report effective detection of ventricular arrhythmias and a reduction in alarm fatigue due to improved alarm accuracy.
What complications have been reported?
Reported complications include alarm fatigue due to false alarms, although design improvements aim to mitigate this issue.
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.