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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device monitor, cardiac (incl. cardiotachometer & rate alarm)
Product CodeDRT
Regulation Number 870.2300
Device Class 2


Premarket Reviews
ManufacturerDecision
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 1
XANDAR KARDIAN INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 447 447
2020 50 50
2021 85 85
2022 39 39
2023 69 69
2024 35 35

Device Problems MDRs with this Device Problem Events in those MDRs
Unable to Obtain Readings 349 349
Overheating of Device 101 101
Output Problem 97 97
Temperature Problem 89 89
Communication or Transmission Problem 46 46
Incorrect, Inadequate or Imprecise Result or Readings 39 39
Protective Measures Problem 25 25
Power Problem 22 22
No Audible Alarm 22 22
Battery Problem 17 17
Application Program Problem 15 15
Display or Visual Feedback Problem 15 15
Patient Data Problem 14 14
Data Problem 12 12
Complete Loss of Power 11 11
Intermittent Communication Failure 10 10
Structural Problem 10 10
No Device Output 9 9
Device Alarm System 9 9
Signal Artifact/Noise 6 6
Electrical /Electronic Property Problem 6 6
Failure of Device to Self-Test 6 6
Loss of Data 6 6
Unexpected Shutdown 5 5
Image Display Error/Artifact 5 5
Computer Software Problem 5 5
Erratic or Intermittent Display 4 4
No Display/Image 4 4
Pacing Problem 4 4
Defibrillation/Stimulation Problem 4 4
Failure to Read Input Signal 4 4
Intermittent Loss of Power 4 4
Patient Device Interaction Problem 4 4
Unintended Electrical Shock 3 3
Wireless Communication Problem 3 3
Appropriate Term/Code Not Available 3 3
Low Readings 3 3
Device Displays Incorrect Message 3 3
Incorrect Measurement 3 3
Failure to Select Signal 2 2
Use of Device Problem 2 2
Failure to Deliver Shock/Stimulation 2 2
Break 2 2
Alarm Not Visible 2 2
No Audible Prompt/Feedback 2 2
High Readings 2 2
Device Sensing Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Contamination /Decontamination Problem 2 2
Electrical Shorting 1 1
Application Network Problem 1 1
Defective Device 1 1
Therapeutic or Diagnostic Output Failure 1 1
Insufficient Information 1 1
Audible Prompt/Feedback Problem 1 1
Unintended Application Program Shut Down 1 1
Erratic Results 1 1
Accessory Incompatible 1 1
Delayed Alarm 1 1
Failure to Charge 1 1
Premature Discharge of Battery 1 1
Use of Incorrect Control/Treatment Settings 1 1
Application Program Problem: Dose Calculation Error 1 1
Improper or Incorrect Procedure or Method 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Failure to Power Up 1 1
Grounding Malfunction 1 1
Incorrect Interpretation of Signal 1 1
Failure to Sense 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 273 273
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 51
Death 12 12
Cardiac Arrest 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Tachycardia 2 2
Unspecified Heart Problem 2 2
Unspecified Tissue Injury 2 2
Insufficient Information 2 2
Fever 1 1
Low Blood Pressure/ Hypotension 1 1
Respiratory Distress Syndrome of Newborns 1 1
Skin Discoloration 1 1
Injury 1 1
Loss of consciousness 1 1
Low Oxygen Saturation 1 1
Electric Shock 1 1

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