• 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)
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
NETEERA TECHNOLOGIES LTD.
  SUBSTANTIALLY EQUIVALENT 1
SLEEPIZ AG
  SUBSTANTIALLY EQUIVALENT 1
VIOS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
XANDAR KARDIAN INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 224 224
2019 447 447
2020 50 50
2021 85 85
2022 39 39
2023 47 47

Device Problems MDRs with this Device Problem Events in those MDRs
Unable to Obtain Readings 469 469
Overheating of Device 138 138
Temperature Problem 105 105
Output Problem 85 85
Communication or Transmission Problem 42 42
Incorrect, Inadequate or Imprecise Result or Readings 42 42
Device Displays Incorrect Message 27 27
Protective Measures Problem 18 18
Misassembly by Users 16 16
Device Issue 15 15
No Audible Alarm 15 15
Battery Problem 14 14
Failure of Device to Self-Test 14 14
Power Problem 13 13
Application Program Problem 13 13
Structural Problem 10 10
Human Factors Issue 10 10
Data Problem 10 10
Device Alarm System 10 10
Defibrillation/Stimulation Problem 10 10
Patient Data Problem 9 9
Electrical /Electronic Property Problem 7 7
Display or Visual Feedback Problem 7 7
Complete Loss of Power 7 7
Appropriate Term/Code Not Available 6 6
No Device Output 6 6
Failure to Read Input Signal 6 6
Loss of Data 6 6
Use of Device Problem 5 5
Computer Software Problem 5 5
Intermittent Communication Failure 5 5
Unexpected Shutdown 4 4
Patient Device Interaction Problem 4 4
No Display/Image 4 4
Pacing Problem 4 4
Incorrect Measurement 4 4
Device Sensing Problem 4 4
Adverse Event Without Identified Device or Use Problem 3 3
Device Operates Differently Than Expected 3 3
Device Operational Issue 3 3
Low Readings 3 3
Inappropriate/Inadequate Shock/Stimulation 3 3
Intermittent Loss of Power 3 3
Unintended Electrical Shock 3 3
Failure to Select Signal 2 2
Incorrect Interpretation of Signal 2 2
Break 2 2
Thermal Decomposition of Device 2 2
Failure to Deliver Shock/Stimulation 2 2
Defective Alarm 2 2
Signal Artifact/Noise 2 2
Insufficient Information 2 2
Wireless Communication Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Electrical Shorting 1 1
Human-Device Interface Problem 1 1
Improper Alarm 1 1
Improper Device Output 1 1
Improper or Incorrect Procedure or Method 1 1
No Audible Prompt/Feedback 1 1
Defective Component 1 1
Invalid Sensing 1 1
Defective Device 1 1
High Readings 1 1
Premature Discharge of Battery 1 1
Alarm Not Visible 1 1
Accessory Incompatible 1 1
Delayed Alarm 1 1
Application Interface Becomes Non-Functional Or Program Exits Abnormally 1 1
Failure to Discharge 1 1
Application Program Problem: Dose Calculation Error 1 1
Failure to Charge 1 1
Use of Incorrect Control/Treatment Settings 1 1
Failure to Sense 1 1
Output above Specifications 1 1
Grounding Malfunction 1 1
Failure to Power Up 1 1
Unintended Application Program Shut Down 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 344 344
No Clinical Signs, Symptoms or Conditions 216 216
No Consequences Or Impact To Patient 142 142
No Known Impact Or Consequence To Patient 106 106
No Information 94 94
Death 22 22
Cardiac Arrest 4 4
Tachycardia 2 2
Injury 2 2
Loss of consciousness 2 2
Unspecified Heart Problem 2 2
Unspecified Tissue Injury 2 2
Insufficient Information 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Low Oxygen Saturation 1 1
Burn, Thermal 1 1
Electric Shock 1 1
Loss Of Pulse 1 1
No Code Available 1 1
Patient Problem/Medical Problem 1 1
Anxiety 1 1
Fever 1 1
Low Blood Pressure/ Hypotension 1 1
Respiratory Distress Syndrome of Newborns 1 1
Skin Discoloration 1 1

-
-