• 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 TECHNOLOGIES, LTD.
  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 1
XANDAR KARDIAN INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 50 50
2021 85 85
2022 38 38
2023 59 59
2024 30 30
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Output Problem 86 86
Overheating of Device 49 49
Temperature Problem 47 47
Communication or Transmission Problem 38 38
Incorrect, Inadequate or Imprecise Result or Readings 32 32
Power Problem 18 18
Protective Measures Problem 16 16
Battery Problem 14 14
Display or Visual Feedback Problem 13 13
Patient Data Problem 13 13
No Audible Alarm 13 13
Application Program Problem 12 12
Data Problem 11 11
Complete Loss of Power 9 9
Intermittent Communication Failure 9 9
Loss of Data 6 6
Signal Artifact/Noise 6 6
Unable to Obtain Readings 6 6
No Device Output 6 6
Computer Software Problem 5 5
Electrical /Electronic Property Problem 5 5
Intermittent Loss of Power 4 4
Image Display Error/Artifact 4 4
Appropriate Term/Code Not Available 3 3
Unexpected Shutdown 3 3
Pacing Problem 3 3
Patient Device Interaction Problem 3 3
No Display/Image 3 3
Device Alarm System 3 3
Erratic or Intermittent Display 3 3
Low Readings 2 2
Break 2 2
Unintended Electrical Shock 2 2
Failure to Select Signal 2 2
Device Sensing Problem 2 2
Contamination /Decontamination Problem 2 2
Unintended Application Program Shut Down 2 2
Device Displays Incorrect Message 2 2
Alarm Not Visible 2 2
High Readings 2 2
Delayed Alarm 1 1
Erratic Results 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Premature Discharge of Battery 1 1
Application Network Problem 1 1
Failure to Deliver Shock/Stimulation 1 1
Wireless Communication Problem 1 1
No Audible Prompt/Feedback 1 1
Grounding Malfunction 1 1
Application Program Problem: Dose Calculation Error 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 245 245
No Consequences Or Impact To Patient 22 22
No Known Impact Or Consequence To Patient 13 13
No Patient Involvement 3 3
Insufficient Information 2 2
Unspecified Heart Problem 2 2
Tachycardia 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Unspecified Tissue Injury 2 2
Cardiac Arrest 1 1
Respiratory Distress Syndrome of Newborns 1 1
Fever 1 1
Low Oxygen Saturation 1 1
Low Blood Pressure/ Hypotension 1 1
Loss of consciousness 1 1
Injury 1 1
Skin Discoloration 1 1

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