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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
CRITICARE SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
FLUKE BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 4
HOANA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
IVY BIOMEDICAL SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 1
IVY BIOMEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 5
MURATA VIOS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NETEERA TECHNOLOGIES LTD.
  SUBSTANTIALLY EQUIVALENT 2
SLEEPIZ AG
  SUBSTANTIALLY EQUIVALENT 1
VIOS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
WIRELESS 2000 RF & UWB TECHNOLOGIES LTD.
  SUBSTANTIALLY EQUIVALENT 1
WR MEDICAL ELECTRONICS CO.
  SUBSTANTIALLY EQUIVALENT 1
XANDAR KARDIAN INC.
  SUBSTANTIALLY EQUIVALENT 1
ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 26 26
2015 48 48
2016 55 55
2017 159 159
2018 224 224
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 512 512
Overheating of Device 179 179
Temperature Problem 151 151
Output Problem 108 108
Device Displays Incorrect Message 82 82
Communication or Transmission Problem 57 57
Incorrect, Inadequate or Imprecise Result or Readings 54 54
Device Operates Differently Than Expected 42 42
Protective Measures Problem 26 26
No Audible Alarm 26 26
Failure of Device to Self-Test 23 23
Power Problem 22 22
Battery Problem 20 20
Device Alarm System 20 20
Device Issue 18 18
Loss of Power 17 17
Application Program Problem 16 16
Misassembly by Users 16 16
Patient Data Problem 15 15
Display or Visual Feedback Problem 15 15
Data Problem 12 12
Device Operational Issue 12 12
Complete Loss of Power 11 11
Defibrillation/Stimulation Problem 11 11
Device Inoperable 11 11
Failure to Read Input Signal 10 10
Structural Problem 10 10
Intermittent Communication Failure 10 10
Human Factors Issue 10 10
Device Sensing Problem 9 9
No Device Output 9 9
Thermal Decomposition of Device 9 9
Electrical /Electronic Property Problem 8 8
No Display/Image 8 8
Pacing Problem 8 8
Failure to Select Signal 7 7
Signal Artifact/Noise 7 7
Image Display Error/Artifact 6 6
Incorrect Measurement 6 6
Invalid Sensing 6 6
Loss of Data 6 6
Appropriate Term/Code Not Available 6 6
Adverse Event Without Identified Device or Use Problem 6 6
Unexpected Shutdown 5 5
Smoking 5 5
Use of Device Problem 5 5
Computer Software Problem 5 5
Erratic or Intermittent Display 4 4
Melted 4 4
Inappropriate/Inadequate Shock/Stimulation 4 4
Incorrect Interpretation of Signal 4 4
Intermittent Loss of Power 4 4
Patient Device Interaction Problem 4 4
Wireless Communication Problem 3 3
Device Handling Problem 3 3
Low Readings 3 3
Unintended Electrical Shock 3 3
Failure to Analyze Signal 3 3
Failure to Power Up 3 3
Break 3 3
Alarm Not Visible 3 3
Premature Discharge of Battery 2 2
Defective Alarm 2 2
Failure to Deliver Shock/Stimulation 2 2
Application Interface Becomes Non-Functional Or Program Exits Abnormally 2 2
Failure to Discharge 2 2
Device Emits Odor 2 2
Failure to Transmit Record 2 2
Self-Activation or Keying 2 2
Failure to Sense 2 2
Radiofrequency Interference (RFI) 2 2
No Audible Prompt/Feedback 2 2
Incorrect Or Inadequate Test Results 2 2
High Readings 2 2
Unintended Application Program Shut Down 2 2
Contamination /Decontamination Problem 2 2
Improper Alarm 2 2
Improper Device Output 2 2
Insufficient Information 2 2
Material Integrity Problem 2 2
Therapeutic or Diagnostic Output Failure 1 1
Operating System Becomes Nonfunctional 1 1
Programming Issue 1 1
Noise, Audible 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Human-Device Interface Problem 1 1
Electrical Shorting 1 1
Sparking 1 1
Application Network Problem 1 1
Erratic Results 1 1
Audible Prompt/Feedback Problem 1 1
Arcing 1 1
Defective Device 1 1
Defective Component 1 1
Improper or Incorrect Procedure or Method 1 1
Electro-Static Discharge 1 1
Tidal Volume Fluctuations 1 1
Device Slipped 1 1
Material Separation 1 1
Increase in Pressure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 416 416
No Clinical Signs, Symptoms or Conditions 275 275
No Known Impact Or Consequence To Patient 246 246
No Consequences Or Impact To Patient 176 176
No Information 133 133
Death 35 35
Cardiac Arrest 6 6
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
Electric Shock 2 2
Injury 2 2
Loss of consciousness 2 2
Low Oxygen Saturation 1 1
Sudden Cardiac Death 1 1
Burn, Thermal 1 1
Loss Of Pulse 1 1
Patient Problem/Medical Problem 1 1
Burn(s) 1 1
Anxiety 1 1
Complaint, Ill-Defined 1 1
Fever 1 1
Head Injury 1 1
Low Blood Pressure/ Hypotension 1 1
Respiratory Distress 1 1
Respiratory Distress Syndrome of Newborns 1 1
Skin Discoloration 1 1
No Code Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ansar Group, Inc. Dba Ansar Medical Technologies, Inc II Aug-19-2014
2 Mindray DS USA, Inc. d.b.a. Mindray North America II Feb-24-2012
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