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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
BRAEMAR MANUFACTURING, LLC
  SUBSTANTIALLY EQUIVALENT 1
GLOBAL INSTRUMENTATION, LLC
  SUBSTANTIALLY EQUIVALENT 1
INFOBIONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
IRHYTHM TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
LIFEWATCH SERVICES, INC
  SUBSTANTIALLY EQUIVALENT 1
LIFEWATCH TECHNOLOGIES LTD.
  SUBSTANTIALLY EQUIVALENT 2
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
NIHON KOHDEN CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
PREVENTICE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
VITASYSTEMS GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 4351 4351
2017 3594 3594
2018 3647 3647
2019 3483 3483
2020 3084 3084
2021 2563 2563

Device Problems MDRs with this Device Problem Events in those MDRs
Under-Sensing 5959 5959
Over-Sensing 3947 3947
Premature Discharge of Battery 3306 3306
No Audible Alarm 1634 1634
Signal Artifact/Noise 1347 1347
Device Sensing Problem 1260 1260
No Audible Prompt/Feedback 825 825
Migration or Expulsion of Device 808 808
Adverse Event Without Identified Device or Use Problem 549 549
Unable to Obtain Readings 517 517
Invalid Sensing 486 486
Reset Problem 422 422
Device Operates Differently Than Expected 420 420
Failure to Interrogate 394 394
Communication or Transmission Problem 375 375
No Device Output 354 354
Device Displays Incorrect Message 345 345
Electromagnetic Interference 342 342
Decreased Sensitivity 299 299
Battery Problem 272 272
Appropriate Term/Code Not Available 249 249
Device Alarm System 245 245
Inaudible or Unclear Audible Prompt/Feedback 220 220
Inappropriate or Unexpected Reset 124 124
Incorrect Measurement 118 118
Defective Device 93 93
Device Inoperable 74 74
Defective Component 73 73
Mechanical Problem 73 73
Output Problem 67 67
Break 58 58
False Positive Result 58 58
Defective Alarm 56 56
Positioning Problem 48 48
Nonstandard Device 46 46
Data Problem 45 45
Insufficient Information 45 45
Device Difficult to Program or Calibrate 42 42
Display or Visual Feedback Problem 41 41
Therapeutic or Diagnostic Output Failure 34 34
No Display/Image 27 27
Protective Measures Problem 26 26
Incorrect, Inadequate or Imprecise Resultor Readings 20 20
Computer Operating System Problem 19 19
Alarm Not Visible 18 18
Noise, Audible 15 15
Loss of Power 14 14
Device Expiration Issue 13 13
Device-Device Incompatibility 13 13
Use of Device Problem 13 13
Patient Device Interaction Problem 13 13
Improper or Incorrect Procedure or Method 12 12
Device Maintenance Issue 12 12
Disconnection 11 11
Battery Impedance Issue 11 11
No Apparent Adverse Event 11 11
Audible Prompt/Feedback Problem 11 11
Low Audible Alarm 10 10
Computer Software Problem 9 9
Loss of Data 9 9
Circuit Failure 8 8
Component Falling 8 8
Failure to Sense 8 8
Failure to Power Up 8 8
Device Fell 8 8
Electrical /Electronic Property Problem 7 7
Detachment of Device or Device Component 7 7
Patient-Device Incompatibility 7 7
Naturally Worn 6 6
Mechanics Altered 6 6
Improper Flow or Infusion 6 6
Overheating of Device 6 6
Difficult to Remove 6 6
Failure to Transmit Record 5 5
Labelling, Instructions for Use or Training Problem 5 5
Improper Device Output 5 5
Device Dislodged or Dislocated 5 5
Connection Problem 5 5
Inappropriate Audible Prompt/Feedback 4 4
Component Missing 4 4
Material Protrusion/Extrusion 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Inadequate Instructions for Non-Healthcare Professional 4 4
Device Operational Issue 4 4
Packaging Problem 4 4
Unintended Movement 4 4
Image Display Error/Artifact 4 4
Telemetry Discrepancy 4 4
Wireless Communication Problem 4 4
Unexpected Shutdown 3 3
Intermittent Communication Failure 3 3
Power Problem 3 3
Material Integrity Problem 3 3
Low Readings 3 3
Sparking 2 2
Application Program Problem 2 2
Device Markings/Labelling Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Human-Device Interface Problem 2 2
No Flow 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 13721 13721
No Clinical Signs, Symptoms or Conditions 2847 2847
No Patient Involvement 1590 1590
No Consequences Or Impact To Patient 1372 1372
Unspecified Infection 315 315
Pain 241 241
Erosion 196 196
Death 103 103
Insufficient Information 75 75
Discomfort 65 65
Impaired Healing 64 64
No Code Available 53 53
Erythema 44 44
Skin Irritation 42 42
Swelling 27 27
Cardiac Arrest 25 25
Purulent Discharge 24 24
Hypersensitivity/Allergic reaction 22 22
Bradycardia 19 19
Chest Pain 18 18
Low Oxygen Saturation 17 17
Dyspnea 16 16
Itching Sensation 16 16
Blood Loss 16 16
Burning Sensation 15 15
No Information 15 15
Dizziness 14 14
Skin Erosion 13 13
Complaint, Ill-Defined 12 12
Injury 11 11
Tachycardia 10 10
Twiddlers Syndrome 10 10
Ventricular Tachycardia 10 10
Cardiopulmonary Arrest 10 10
Bruise/Contusion 9 9
Syncope 9 9
Hematoma 8 8
Rash 8 8
Palpitations 8 8
Loss of consciousness 8 8
Burn(s) 7 7
Pocket Erosion 7 7
Arrhythmia 6 6
Bacterial Infection 6 6
Ventricular Fibrillation 6 6
Burn, Thermal 6 6
Wound Dehiscence 6 6
Fall 6 6
Skin Discoloration 6 6
Low Blood Pressure/ Hypotension 5 5
Seizures 5 5
Cellulitis 5 5
Skin Inflammation/ Irritation 5 5
Stroke/CVA 4 4
Hemorrhage/Bleeding 4 4
Hypoxia 4 4
Electric Shock 4 4
Loss Of Pulse 4 4
Irritation 4 4
Skin Inflammation 4 4
Twiddlers Syndrome 4 4
Sweating 3 3
Fluid Discharge 3 3
Discharge 3 3
Sudden Cardiac Death 3 3
Sepsis 3 3
Inflammation 3 3
Fever 3 3
Endocarditis 3 3
Shock 3 3
Patient Problem/Medical Problem 3 3
Swelling/ Edema 3 3
Tissue Breakdown 2 2
Tissue Damage 2 2
Scarring 2 2
Weakness 2 2
Chest Tightness/Pressure 2 2
Anxiety 2 2
Diabetic Ketoacidosis 2 2
Reaction 2 2
Irritability 2 2
Head Injury 2 2
Respiratory Distress 2 2
Undesired Nerve Stimulation 2 2
Pneumothorax 2 2
Edema 2 2
Apnea 2 2
Atrial Fibrillation 2 2
Cyanosis 2 2
Fatigue 2 2
Increased Sensitivity 2 2
Transient Ischemic Attack 2 2
Skin Tears 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Partial thickness (Second Degree) Burn 1 1
Lead(s), Burn(s) From 1 1
Shock from Patient Lead(s) 1 1
Skin Burning Sensation 1 1
Sleep Dysfunction 1 1
Ambulation Difficulties 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 Medtronic Inc. II Mar-25-2016
4 Philips Electronics North America Corporation II Dec-10-2018
5 Philips Electronics North America Corporation II Jun-11-2018
6 Philips Electronics North America Corporation II Apr-04-2017
7 Philips North America, LLC II Jul-10-2020
8 Philips North America, LLC II Jun-01-2019
9 Philips North America Llc II May-21-2021
10 Philips North America Llc II Dec-08-2020
11 Preventice Services, LLC II Jul-01-2020
12 Scottcare Corporation II Apr-01-2016
13 Spacelabs Healthcare Inc II Aug-04-2016
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