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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device detector and alarm, arrhythmia
Regulation Description Arrhythmia detector and alarm (including ST-segment measurement and alarm).
Product CodeDSI
Regulation Number 870.1025
Device Class 2


Premarket Reviews
ManufacturerDecision
IRHYTHM TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
LIFEWATCH SERVICES, INC
  SUBSTANTIALLY EQUIVALENT 1
MEDICALGORITHMICS S.A.
  SUBSTANTIALLY EQUIVALENT 2
MEDICOMP, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC
  SUBSTANTIALLY EQUIVALENT 1
MEMTEC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
NATIONAL CARDIAC, INC.
  SUBSTANTIALLY EQUIVALENT 1
PREVENTICE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 3594 3594
2018 3647 3647
2019 3483 3483
2020 3084 3084
2021 3091 3091

Device Problems MDRs with this Device Problem Events in those MDRs
Under-Sensing 5409 5409
Over-Sensing 3652 3652
No Audible Alarm 1561 1561
Signal Artifact/Noise 1321 1321
Device Sensing Problem 1245 1245
Premature Discharge of Battery 1011 1011
No Audible Prompt/Feedback 834 834
Migration or Expulsion of Device 627 627
Adverse Event Without Identified Device or Use Problem 526 526
Unable to Obtain Readings 480 480
Invalid Sensing 467 467
Reset Problem 430 430
Electromagnetic Interference 350 350
Communication or Transmission Problem 344 344
Failure to Interrogate 339 339
Device Operates Differently Than Expected 298 298
Decreased Sensitivity 298 298
Device Displays Incorrect Message 293 293
No Device Output 241 241
Appropriate Term/Code Not Available 234 234
Battery Problem 229 229
Inaudible or Unclear Audible Prompt/Feedback 212 212
Device Alarm System 169 169
Inappropriate or Unexpected Reset 143 143
Incorrect Measurement 104 104
Defective Device 92 92
Defective Component 73 73
Mechanical Problem 63 63
Device Inoperable 62 62
Output Problem 61 61
Defective Alarm 56 56
Break 49 49
Data Problem 46 46
Device Difficult to Program or Calibrate 45 45
Display or Visual Feedback Problem 43 43
Insufficient Information 39 39
Positioning Problem 35 35
Therapeutic or Diagnostic Output Failure 34 34
Alarm Not Visible 27 27
Protective Measures Problem 22 22
Patient Device Interaction Problem 21 21
Nonstandard Device 21 21
Incorrect, Inadequate or Imprecise Resultor Readings 21 21
Computer Operating System Problem 17 17
Use of Device Problem 16 16
No Display/Image 15 15
Device-Device Incompatibility 15 15
Noise, Audible 15 15
Low Audible Alarm 14 14
Disconnection 11 11
No Apparent Adverse Event 11 11
Audible Prompt/Feedback Problem 11 11
Loss of Power 10 10
Computer Software Problem 9 9
Loss of Data 9 9
Device Fell 8 8
Circuit Failure 8 8
Device Expiration Issue 8 8
False Positive Result 8 8
Improper or Incorrect Procedure or Method 8 8
Failure to Sense 8 8
Difficult to Remove 7 7
Failure to Power Up 7 7
Detachment of Device or Device Component 7 7
Patient-Device Incompatibility 7 7
Improper Flow or Infusion 6 6
Mechanics Altered 6 6
Naturally Worn 6 6
Failure to Transmit Record 6 6
Overheating of Device 6 6
Electrical /Electronic Property Problem 6 6
Labelling, Instructions for Use or Training Problem 5 5
Connection Problem 5 5
Device Dislodged or Dislocated 5 5
Inadequate Instructions for Non-Healthcare Professional 4 4
Improper Device Output 4 4
Device Operational Issue 4 4
Telemetry Discrepancy 4 4
Material Protrusion/Extrusion 4 4
Wireless Communication Problem 4 4
Unintended Movement 4 4
Inappropriate Audible Prompt/Feedback 4 4
Image Display Error/Artifact 3 3
Packaging Problem 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Material Integrity Problem 3 3
Low Readings 3 3
Battery Impedance Issue 3 3
Human-Device Interface Problem 3 3
Unexpected Shutdown 3 3
Intermittent Communication Failure 3 3
Device Contamination with Chemical or Other Material 2 2
Device Markings/Labelling Problem 2 2
Application Program Problem 2 2
Capturing Problem 2 2
Sparking 2 2
No Flow 2 2
Moisture or Humidity Problem 2 2
Operating System Becomes Nonfunctional 2 2
Power Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 9952 9952
No Clinical Signs, Symptoms or Conditions 3316 3316
No Consequences Or Impact To Patient 1280 1280
No Patient Involvement 1274 1274
Unspecified Infection 300 300
Pain 210 210
Erosion 194 194
Death 83 83
Insufficient Information 82 82
Impaired Healing 58 58
Discomfort 54 54
Erythema 42 42
Skin Irritation 41 41
No Code Available 39 39
Hypersensitivity/Allergic reaction 29 29
Cardiac Arrest 27 27
Purulent Discharge 23 23
Swelling 21 21
Low Oxygen Saturation 16 16
Bradycardia 15 15
Blood Loss 13 13
Burning Sensation 12 12
Dizziness 12 12
Chest Pain 12 12
Dyspnea 12 12
Skin Erosion 12 12
Itching Sensation 12 12
Cardiopulmonary Arrest 10 10
No Information 10 10
Skin Inflammation/ Irritation 9 9
Complaint, Ill-Defined 9 9
Injury 9 9
Loss of consciousness 9 9
Rash 9 9
Bruise/Contusion 8 8
Tachycardia 7 7
Burn(s) 6 6
Syncope 6 6
Arrhythmia 6 6
Bacterial Infection 6 6
Hematoma 6 6
Burn, Thermal 6 6
Palpitations 5 5
Electric Shock 5 5
Twiddlers Syndrome 5 5
Hypoxia 5 5
Cellulitis 5 5
Twiddlers Syndrome 5 5
Seizures 5 5
Skin Discoloration 5 5
Pocket Erosion 5 5
Irritation 4 4
Ventricular Fibrillation 4 4
Ventricular Tachycardia 4 4
Wound Dehiscence 4 4
Hemorrhage/Bleeding 4 4
Fall 4 4
Swelling/ Edema 4 4
Skin Inflammation 4 4
Sweating 3 3
Sudden Cardiac Death 3 3
Loss Of Pulse 3 3
Discharge 3 3
Patient Problem/Medical Problem 3 3
Stroke/CVA 3 3
Shock 3 3
Inflammation 3 3
Undesired Nerve Stimulation 2 2
Pneumothorax 2 2
Respiratory Distress 2 2
Scar Tissue 2 2
Scarring 2 2
Increased Sensitivity 2 2
Sepsis 2 2
Tissue Damage 2 2
Weakness 2 2
Atrial Fibrillation 2 2
Cyanosis 2 2
Edema 2 2
Fever 2 2
Low Blood Pressure/ Hypotension 2 2
Tissue Breakdown 2 2
Fluid Discharge 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Unspecified Tissue Injury 2 2
Anxiety 2 2
Irritability 2 2
Reaction 2 2
Diabetic Ketoacidosis 2 2
Skin Tears 2 2
Sleep Dysfunction 1 1
Diaphoresis 1 1
Chest Tightness/Pressure 1 1
Ambulation Difficulties 1 1
Caustic/Chemical Burns 1 1
Confusion/ Disorientation 1 1
Breast Mass 1 1
Joint Swelling 1 1
Myalgia 1 1
Tingling 1 1

Recalls
Manufacturer Recall Class Date Posted
1 GE Healthcare, LLC II Dec-20-2019
2 GE Healthcare, LLC II Oct-23-2019
3 Philips Electronics North America Corporation II Dec-10-2018
4 Philips Electronics North America Corporation II Jun-11-2018
5 Philips Electronics North America Corporation II Apr-04-2017
6 Philips North America, LLC II Jul-10-2020
7 Philips North America, LLC II Jun-01-2019
8 Philips North America Llc II May-21-2021
9 Philips North America Llc II Dec-08-2020
10 Preventice Services, LLC II Jul-01-2020
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