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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)
Regulation Description Cardiac monitor (including cardiotachometer and 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 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
2016 55 55
2017 159 159
2018 224 224
2019 447 447
2020 49 49
2021 70 70

Device Problems MDRs with this Device Problem Events in those MDRs
Unable to Obtain Readings 508 508
Overheating of Device 153 153
Temperature Problem 124 124
Device Displays Incorrect Message 73 73
Output Problem 53 53
Communication or Transmission Problem 33 33
Incorrect, Inadequate or Imprecise Resultor Readings 27 27
Failure of Device to Self-Test 23 23
Device Operates Differently Than Expected 19 19
Misassembly by Users 16 16
Device Issue 15 15
Defibrillation/Stimulation Problem 11 11
Battery Problem 10 10
Structural Problem 10 10
Human Factors Issue 10 10
Device Operational Issue 9 9
Application Program Problem 9 9
Failure to Read Input Signal 9 9
Thermal Decomposition of Device 9 9
Device Inoperable 8 8
Device Alarm System 7 7
Protective Measures Problem 7 7
Incorrect Measurement 6 6
No Audible Alarm 6 6
Pacing Problem 6 6
Electrical /Electronic Property Problem 6 6
Failure to Select Signal 6 6
Invalid Sensing 6 6
Device Sensing Problem 6 6
Adverse Event Without Identified Device or Use Problem 6 6
Data Problem 5 5
Loss of Data 5 5
Computer Software Problem 5 5
Loss of Power 5 5
Smoking 5 5
Use of Device Problem 5 5
Appropriate Term/Code Not Available 5 5
No Device Output 4 4
No Display/Image 4 4
Melted 4 4
Incorrect Interpretation of Signal 4 4
Display or Visual Feedback Problem 3 3
Failure to Power Up 3 3
Patient Data Problem 3 3
Unintended Electrical Shock 3 3
Inappropriate/Inadequate Shock/Stimulation 3 3
Failure to Analyze Signal 3 3
Power Problem 3 3
Low Readings 2 2
Improper Alarm 2 2
Improper Device Output 2 2
Defective Alarm 2 2
Patient Device Interaction Problem 2 2
Intermittent Loss of Power 2 2
Device Handling Problem 2 2
Insufficient Information 2 2
Incorrect Or Inadequate Test Results 2 2
Failure to Sense 2 2
Device Emits Odor 2 2
Failure to Deliver Shock/Stimulation 2 2
Failure to Discharge 2 2
Device Slipped 1 1
Fire 1 1
Fluid Leak 1 1
Hole In Material 1 1
Inflation Problem 1 1
Signal Artifact/Noise 1 1
Break 1 1
Burst Container or Vessel 1 1
Failure to Charge 1 1
Use of Incorrect Control Settings 1 1
Defective Device 1 1
Sparking 1 1
Human-Device Interface Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Noise, Audible 1 1
Wireless Communication Problem 1 1
Unexpected Shutdown 1 1
Unintended Application Program Shut Down 1 1
Alarm Not Visible 1 1
Premature Discharge of Battery 1 1
Application Interface Becomes Non-Functional Or Program Exits Abnormally 1 1
Material Discolored 1 1
Grounding Malfunction 1 1
Image Display Error/Artifact 1 1
Output above Specifications 1 1
Accessory Incompatible 1 1
Failure to Transmit Record 1 1
Material Integrity Problem 1 1
Arcing 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
Electrical Shorting 1 1
Intermittent Communication Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 406 406
No Known Impact Or Consequence To Patient 199 199
No Consequences Or Impact To Patient 167 167
No Information 129 129
No Clinical Signs, Symptoms or Conditions 87 87
Death 33 33
Cardiac Arrest 5 5
Unspecified Tissue Injury 2 2
Injury 2 2
Unspecified Heart Problem 2 2
Insufficient Information 1 1
Loss of consciousness 1 1
Sudden Cardiac Death 1 1
Burn(s) 1 1
Skin Discoloration 1 1
Burn, Thermal 1 1
Electric Shock 1 1
Loss Of Pulse 1 1
Tachycardia 1 1
Anxiety 1 1
Patient Problem/Medical Problem 1 1
No Code Available 1 1

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