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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 1898 1898

Device Problems MDRs with this Device Problem Events in those MDRs
Under-Sensing 5865 5865
Over-Sensing 3898 3898
Premature Discharge of Battery 3300 3300
No Audible Alarm 1574 1574
Signal Artifact/Noise 1320 1320
Device Sensing Problem 1228 1228
Migration or Expulsion of Device 793 793
No Audible Prompt/Feedback 705 705
Adverse Event Without Identified Device or Use Problem 529 529
Unable to Obtain Readings 505 505
Invalid Sensing 486 486
Device Operates Differently Than Expected 420 420
Failure to Interrogate 379 379
No Device Output 353 353
Device Displays Incorrect Message 345 345
Communication or Transmission Problem 341 341
Electromagnetic Interference 322 322
Decreased Sensitivity 294 294
Battery Problem 267 267
Reset Problem 251 251
Appropriate Term/Code Not Available 244 244
Device Alarm System 242 242
Inaudible or Unclear Audible Prompt/Feedback 220 220
Incorrect Measurement 118 118
Defective Device 93 93
Inappropriate or Unexpected Reset 91 91
Device Inoperable 74 74
Defective Component 73 73
Mechanical Problem 72 72
Output Problem 64 64
False Positive Result 58 58
Break 58 58
Defective Alarm 52 52
Positioning Problem 48 48
Nonstandard Device 46 46
Insufficient Information 45 45
Data Problem 42 42
Device Difficult to Program or Calibrate 39 39
Display or Visual Feedback Problem 36 36
Therapeutic or Diagnostic Output Failure 33 33
No Display/Image 27 27
Protective Measures Problem 25 25
Computer Operating System Problem 18 18
Incorrect, Inadequate or Imprecise Resultor Readings 18 18
Alarm Not Visible 17 17
Noise, Audible 16 16
Loss of Power 14 14
Device Expiration Issue 13 13
Use of Device Problem 13 13
Improper or Incorrect Procedure or Method 13 13
Device Maintenance Issue 12 12
Patient Device Interaction Problem 12 12
Battery Impedance Issue 11 11
Device-Device Incompatibility 11 11
No Apparent Adverse Event 11 11
Audible Prompt/Feedback Problem 11 11
Disconnection 10 10
Loss of Data 9 9
Component Falling 8 8
Circuit Failure 8 8
Failure to Power Up 8 8
Failure to Sense 7 7
Low Audible Alarm 7 7
Device Fell 7 7
Detachment of Device or Device Component 7 7
Computer Software Problem 7 7
Electrical /Electronic Property Problem 7 7
Mechanics Altered 6 6
Patient-Device Incompatibility 6 6
Improper Flow or Infusion 6 6
Naturally Worn 6 6
Overheating of Device 6 6
Labelling, Instructions for Use or Training Problem 5 5
Device Dislodged or Dislocated 5 5
Difficult to Remove 5 5
Improper Device Output 5 5
Connection Problem 5 5
Failure to Transmit Record 5 5
Image Display Error/Artifact 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Telemetry Discrepancy 4 4
Component Missing 4 4
Device Operational Issue 4 4
Inadequate Instructions for Non-Healthcare Professional 4 4
Material Protrusion/Extrusion 4 4
Unintended Movement 4 4
Wireless Communication Problem 4 4
Unexpected Shutdown 3 3
Packaging Problem 3 3
Inappropriate Audible Prompt/Feedback 3 3
Material Integrity Problem 3 3
Power Problem 3 3
Low Readings 3 3
Device Markings/Labelling Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Premature Elective Replacement Indicator 2 2
Self-Activation or Keying 2 2
Loose or Intermittent Connection 2 2
Thermal Decomposition of Device 2 2
Failure to Capture 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 2212 2212
No Patient Involvement 1590 1590
No Consequences Or Impact To Patient 1372 1372
Unspecified Infection 306 306
Pain 236 236
Erosion 193 193
Death 103 103
Insufficient Information 73 73
Discomfort 64 64
Impaired Healing 61 61
No Code Available 53 53
Erythema 43 43
Skin Irritation 42 42
Swelling 27 27
Purulent Discharge 24 24
Cardiac Arrest 23 23
Hypersensitivity/Allergic reaction 22 22
Chest Pain 18 18
Bradycardia 18 18
Low Oxygen Saturation 17 17
Dyspnea 16 16
Blood Loss 16 16
Burning Sensation 15 15
Itching Sensation 15 15
No Information 15 15
Dizziness 14 14
Complaint, Ill-Defined 12 12
Skin Erosion 12 12
Injury 11 11
Twiddlers Syndrome 10 10
Ventricular Tachycardia 10 10
Cardiopulmonary Arrest 10 10
Tachycardia 9 9
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
Stroke/CVA 4 4
Hemorrhage/Bleeding 4 4
Electric Shock 4 4
Loss Of Pulse 4 4
Skin Inflammation/ Irritation 4 4
Irritation 4 4
Skin Inflammation 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
Swelling/ Edema 3 3
Patient Problem/Medical Problem 3 3
Shock 3 3
Hypoxia 3 3
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
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
Tissue Breakdown 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
Twiddlers Syndrome 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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