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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
CONNECTED SENSING- A DIVISION OF PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
IVY BIOMEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
VIOS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
XANDAR KARDIAN INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 159 159
2018 224 224
2019 447 447
2020 49 49
2021 85 85
2022 18 18

Device Problems MDRs with this Device Problem Events in those MDRs
Unable to Obtain Readings 508 508
Overheating of Device 145 145
Temperature Problem 129 129
Output Problem 64 64
Device Displays Incorrect Message 64 64
Communication or Transmission Problem 31 31
Incorrect, Inadequate or Imprecise Resultor Readings 31 31
Failure of Device to Self-Test 20 20
Misassembly by Users 16 16
Device Issue 15 15
Application Program Problem 12 12
Battery Problem 11 11
Defibrillation/Stimulation Problem 11 11
Structural Problem 10 10
Human Factors Issue 10 10
Device Operates Differently Than Expected 10 10
Failure to Read Input Signal 8 8
Pacing Problem 7 7
Device Alarm System 7 7
Protective Measures Problem 7 7
Appropriate Term/Code Not Available 6 6
Data Problem 6 6
No Audible Alarm 6 6
Thermal Decomposition of Device 6 6
Incorrect Measurement 6 6
Device Operational Issue 6 6
Loss of Data 5 5
Adverse Event Without Identified Device or Use Problem 5 5
Use of Device Problem 5 5
Invalid Sensing 5 5
Computer Software Problem 5 5
Electrical /Electronic Property Problem 5 5
No Display/Image 4 4
No Device Output 4 4
Smoking 4 4
Device Sensing Problem 4 4
Power Problem 3 3
Failure to Select Signal 3 3
Inappropriate/Inadequate Shock/Stimulation 3 3
Failure to Analyze Signal 3 3
Incorrect Interpretation of Signal 3 3
Display or Visual Feedback Problem 3 3
Patient Data Problem 3 3
Unintended Electrical Shock 3 3
Unexpected Shutdown 2 2
Insufficient Information 2 2
Patient Device Interaction Problem 2 2
Intermittent Loss of Power 2 2
Failure to Deliver Shock/Stimulation 2 2
Defective Alarm 2 2
Failure to Sense 2 2
Device Emits Odor 2 2
Failure to Power Up 2 2
Low Readings 2 2
Improper Alarm 2 2
Improper Device Output 2 2
Therapeutic or Diagnostic Output Failure 1 1
Electrical Shorting 1 1
Human-Device Interface Problem 1 1
Incorrect Or Inadequate Test Results 1 1
Defective Device 1 1
Device Inoperable 1 1
Improper or Incorrect Procedure or Method 1 1
Electro-Static Discharge 1 1
No Audible Prompt/Feedback 1 1
Defective Component 1 1
Output above Specifications 1 1
Melted 1 1
Accessory Incompatible 1 1
Loss of Power 1 1
Failure to Transmit Record 1 1
Alarm Not Visible 1 1
Signal Artifact/Noise 1 1
Use of Incorrect Control Settings 1 1
Failure to Charge 1 1
Application Interface Becomes Non-Functional Or Program Exits Abnormally 1 1
Failure to Discharge 1 1
Material Discolored 1 1
Grounding Malfunction 1 1
Image Display Error/Artifact 1 1
Wireless Communication Problem 1 1
Unintended Application Program Shut Down 1 1
Intermittent Communication Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 399 399
No Consequences Or Impact To Patient 163 163
No Known Impact Or Consequence To Patient 159 159
No Information 127 127
No Clinical Signs, Symptoms or Conditions 127 127
Death 31 31
Cardiac Arrest 5 5
Unspecified Heart Problem 2 2
Unspecified Tissue Injury 2 2
Injury 2 2
Loss of consciousness 1 1
Sudden Cardiac Death 1 1
Burn, Thermal 1 1
Electric Shock 1 1
Loss Of Pulse 1 1
Skin Discoloration 1 1
Tachycardia 1 1
Anxiety 1 1
Insufficient Information 1 1
No Code Available 1 1
Patient Problem/Medical Problem 1 1

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