Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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
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 24 24

Device Problems MDRs with this Device Problem Events in those MDRs
Unable to Obtain Readings 511 511
Overheating of Device 179 179
Temperature Problem 151 151
Output Problem 106 106
Device Displays Incorrect Message 82 82
Communication or Transmission Problem 57 57
Incorrect, Inadequate or Imprecise Result or Readings 52 52
Device Operates Differently Than Expected 42 42
Failure of Device to Self-Test 23 23
Protective Measures Problem 23 23
No Audible Alarm 22 22
Power Problem 20 20
Battery Problem 19 19
Device Alarm System 19 19
Device Issue 18 18
Loss of Power 17 17
Misassembly by Users 16 16
Application Program Problem 15 15
Display or Visual Feedback Problem 15 15
Patient Data Problem 13 13
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
Human Factors Issue 10 10
Device Sensing Problem 9 9
Intermittent Communication Failure 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
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
Patient Device Interaction Problem 4 4
Unexpected Shutdown 4 4
Intermittent Loss of Power 3 3
Unintended Electrical Shock 3 3
Wireless Communication Problem 3 3
Device Handling Problem 3 3
Low Readings 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
Contamination /Decontamination Problem 2 2
Improper Alarm 2 2
Improper Device Output 2 2
Insufficient Information 2 2
Material Integrity Problem 2 2
Unintended Application Program Shut Down 2 2
Erratic Results 1 1
Audible Prompt/Feedback Problem 1 1
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
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 264 264
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
-
-