Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device monitor, cardiac (incl. cardiotachometer & rate alarm)
Regulation Description Cardiac monitor (including cardiotachometer and rate alarm).
Product CodeDRT
Regulation Number 870.2300
Device Class 2


Premarket Reviews
ManufacturerDecision
CIRCADIA HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 2
CIRCADIA TECHNOLOGIES, LTD.
  SUBSTANTIALLY EQUIVALENT 1
CONNECTED SENSING- A DIVISION OF PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
IVY BIOMEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MURATA VIOS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NETEERA TECHNOLOGIES , LTD.
  SUBSTANTIALLY EQUIVALENT 2
SLEEPIZ AG
  SUBSTANTIALLY EQUIVALENT 3
XANDAR KARDIAN, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 447 448
2020 50 51
2021 85 85
2022 35 35
2023 47 47
2024 29 29
2025 40 40
2026 40 40

Device Problems MDRs with this Device Problem Events in those MDRs
Unable to Obtain Readings 359 359
Output Problem 122 123
Overheating of Device 99 99
Temperature Problem 87 87
Incorrect, Inadequate or Imprecise Result or Readings 60 60
Communication or Transmission Problem 57 58
Display or Visual Feedback Problem 25 26
Power Problem 21 21
Protective Measures Problem 18 18
Battery Problem 16 16
Application Program Problem 13 13
Intermittent Communication Failure 12 13
Complete Loss of Power 12 12
Data Problem 11 11
No Audible Alarm 11 11
Patient Data Problem 11 11
Signal Artifact/Noise 11 11
No Display/Image 10 10
Structural Problem 10 10
No Device Output 9 9
Failure to Read Input Signal 6 6
Loss of Data 6 6
Electrical /Electronic Property Problem 6 6
Device Alarm System 6 6
Image Display Error/Artifact 6 6
Failure of Device to Self-Test 5 5
Computer Software Problem 5 5
Intermittent Loss of Power 4 4
Defibrillation/Stimulation Problem 4 4
Patient Device Interaction Problem 4 4
Incorrect Measurement 3 3
Low Readings 3 3
Appropriate Device Problem Term/Code Not Available 3 3
Erratic or Intermittent Display 3 3
Pacing Problem 3 3
Unexpected Shutdown 3 3
Wireless Communication Problem 3 3
Failure to Select Signal 2 2
Device Sensing Problem 2 2
Use of Device Problem 2 2
Unintended Electrical Shock 2 2
Unintended Application Program Shut Down 2 2
Premature Discharge of Battery 2 2
Contamination /Decontamination Problem 2 2
High Readings 2 2
Application Program Problem: Dose Calculation Error 1 2
Insufficient Device Problem Information 1 1
Battery Problem: Low Impedance 1 1
Adverse Event Without Identified Device or Use Problem 1 1
False Alarm 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 316 317
No Patient Involvement 247 247
No Consequences Or Impact To Patient 120 120
No Information 55 55
No Known Impact Or Consequence To Patient 51 52
Death 12 12
Insufficient Information 4 4
Cardiac Arrest 3 4
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 3 3
Arrhythmia 2 2
Tachycardia 2 2
Unspecified Tissue Injury 2 2
Unspecified Heart Problem 2 2
Electric Shock 1 1
Sepsis 1 1
Skin Discoloration 1 1
Fever 1 1
Injury 1 1
Asystole 1 1
Partial thickness (Second Degree) Burn 1 1
Respiratory Distress Syndrome of Newborns 1 1
Loss of consciousness 1 1
Low Blood Pressure/ Hypotension 1 1
Low Oxygen Saturation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Murata Vios, Inc. II Mar-06-2025
2 Murata Vios, Inc. II Feb-12-2025
3 Murata Vios, Inc. II Jan-30-2025
4 Murata Vios, Inc. II Jan-16-2025
-
-