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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
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 3093 3093
2022 1366 1366

Device Problems MDRs with this Device Problem Events in those MDRs
Under-Sensing 5624 5624
Over-Sensing 3798 3798
No Audible Alarm 2021 2021
Signal Artifact/Noise 1381 1381
Device Sensing Problem 1299 1299
Premature Discharge of Battery 1019 1019
No Audible Prompt/Feedback 927 927
Migration or Expulsion of Device 682 682
Adverse Event Without Identified Device or Use Problem 596 596
Unable to Obtain Readings 517 517
Reset Problem 477 477
Invalid Sensing 467 467
Communication or Transmission Problem 417 417
Electromagnetic Interference 371 371
Failure to Interrogate 366 366
Decreased Sensitivity 302 302
Device Operates Differently Than Expected 298 298
Device Displays Incorrect Message 293 293
Appropriate Term/Code Not Available 250 250
No Device Output 245 245
Battery Problem 235 235
Inaudible or Unclear Audible Prompt/Feedback 214 214
Device Alarm System 193 193
Inappropriate or Unexpected Reset 146 146
Incorrect Measurement 110 110
Defective Device 92 92
Defective Component 73 73
Output Problem 72 72
Defective Alarm 69 69
Mechanical Problem 64 64
Device Inoperable 62 62
Data Problem 58 58
Device Difficult to Program or Calibrate 57 57
Break 50 50
Insufficient Information 47 47
Display or Visual Feedback Problem 46 46
Patient Device Interaction Problem 39 39
Positioning Problem 37 37
Therapeutic or Diagnostic Output Failure 36 36
Alarm Not Visible 35 35
Incorrect, Inadequate or Imprecise Result or Readings 27 27
Protective Measures Problem 22 22
Use of Device Problem 21 21
Nonstandard Device 21 21
Device-Device Incompatibility 18 18
Computer Operating System Problem 18 18
Low Audible Alarm 17 17
No Display/Image 16 16
Noise, Audible 15 15
Computer Software Problem 14 14
Audible Prompt/Feedback Problem 14 14
Detachment of Device or Device Component 12 12
Patient-Device Incompatibility 12 12
No Apparent Adverse Event 11 11
Disconnection 11 11
Failure to Transmit Record 11 11
Loss of Power 10 10
Loss of Data 10 10
Human-Device Interface Problem 10 10
Improper or Incorrect Procedure or Method 9 9
Failure to Sense 8 8
Difficult to Remove 8 8
Failure to Power Up 8 8
Electrical /Electronic Property Problem 8 8
False Positive Result 8 8
Device Expiration Issue 8 8
Circuit Failure 8 8
Device Fell 8 8
Delayed Alarm 7 7
Labelling, Instructions for Use or Training Problem 6 6
Overheating of Device 6 6
Mechanics Altered 6 6
Naturally Worn 6 6
Improper Flow or Infusion 6 6
Device Dislodged or Dislocated 5 5
Connection Problem 5 5
Loose or Intermittent Connection 5 5
Telemetry Discrepancy 5 5
Intermittent Communication Failure 5 5
Inappropriate Audible Prompt/Feedback 4 4
Fire 4 4
Use of Incorrect Control/Treatment Settings 4 4
Device Operational Issue 4 4
Inadequate Instructions for Non-Healthcare Professional 4 4
Improper Device Output 4 4
Wireless Communication Problem 4 4
Patient Data Problem 4 4
Material Protrusion/Extrusion 4 4
Unintended Movement 4 4
Power Problem 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Material Integrity Problem 3 3
Packaging Problem 3 3
Low Readings 3 3
Sparking 3 3
Application Program Problem 3 3
Battery Impedance Issue 3 3
Image Display Error/Artifact 3 3
Device Difficult to Setup or Prepare 3 3
Missing Test Results 3 3

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 4503 4503
No Consequences Or Impact To Patient 1280 1280
No Patient Involvement 1274 1274
Unspecified Infection 337 337
Pain 236 236
Erosion 215 215
Insufficient Information 133 133
Death 83 83
Impaired Healing 60 60
Discomfort 59 59
Erythema 52 52
Skin Irritation 41 41
Hypersensitivity/Allergic reaction 39 39
No Code Available 39 39
Cardiac Arrest 35 35
Purulent Discharge 24 24
Swelling 21 21
Low Oxygen Saturation 20 20
Skin Inflammation/ Irritation 19 19
Bradycardia 18 18
Itching Sensation 14 14
Chest Pain 13 13
Blood Loss 13 13
Dizziness 13 13
Skin Erosion 12 12
Burning Sensation 12 12
Dyspnea 12 12
Arrhythmia 12 12
Cardiopulmonary Arrest 10 10
Rash 10 10
No Information 10 10
Complaint, Ill-Defined 9 9
Injury 9 9
Loss of consciousness 9 9
Tachycardia 9 9
Bruise/Contusion 9 9
Hematoma 8 8
Cellulitis 7 7
Bacterial Infection 7 7
Twiddlers Syndrome 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Blister 6 6
Burn, Thermal 6 6
Syncope 6 6
Burn(s) 6 6
Hemorrhage/Bleeding 6 6
Skin Discoloration 6 6
Pocket Erosion 6 6
Hypoxia 6 6
Seizures 5 5
Twiddlers Syndrome 5 5
Ventricular Fibrillation 5 5
Palpitations 5 5
Swelling/ Edema 5 5
Electric Shock 5 5
Asystole 4 4
Skin Tears 4 4
Skin Inflammation 4 4
Ventricular Tachycardia 4 4
Irritation 4 4
Fall 4 4
Wound Dehiscence 4 4
Stroke/CVA 3 3
Inflammation 3 3
Shock 3 3
Sweating 3 3
Sudden Cardiac Death 3 3
Discharge 3 3
Skin Infection 3 3
Loss Of Pulse 3 3
Patient Problem/Medical Problem 3 3
Tissue Breakdown 3 3
Fluid Discharge 2 2
Caustic/Chemical Burns 2 2
Unspecified Respiratory Problem 2 2
Skin Burning Sensation 2 2
Anxiety 2 2
Diabetic Ketoacidosis 2 2
Weakness 2 2
Rupture 2 2
Respiratory Failure 2 2
Irritability 2 2
Reaction 2 2
Increased Sensitivity 2 2
Sepsis 2 2
Scar Tissue 2 2
Scarring 2 2
Tissue Damage 2 2
Headache 2 2
Undesired Nerve Stimulation 2 2
Myocardial Infarction 2 2
Pneumothorax 2 2
Respiratory Distress 2 2
Apnea 2 2
Atrial Fibrillation 2 2
Fever 2 2
Hair Loss 2 2
Low Blood Pressure/ Hypotension 2 2
Hypothermia 2 2

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
11 iRhythm Technologies, Inc. II Nov-04-2022
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