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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device automated external defibrillators (non-wearable)
Regulation Description Automated external defibrillator system.
Definition This device is a non-wearable prescription use only aed. These are devices that include automated external defibrillation. Automated external defibrillators use external pad-type electrodes to sense, detect, classify and treat (with an electrical shock) ventricular fibrillation. These devices are intended to be used on suspected victims of sudden cardiac arrest. A person in cardiac arrest is unresponsive and is not breathing normally. The device can be sold with prescription only.
Product CodeMKJ
Regulation Number 870.5310
Device Class 3

Premarket Approvals (PMA)
2016 2017 2018 2019 2020 2021
0 4 20 25 52 17

MDR Year MDR Reports MDR Events
2016 17063 17063
2017 16681 16681
2018 16586 16586
2019 16859 16859
2020 16196 16196
2021 5194 5194

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operates Differently Than Expected 12626 12626
Failure to Power Up 8797 8797
Failure of Device to Self-Test 8598 8598
Device Displays Incorrect Message 6341 6341
Self-Activation or Keying 3434 3434
No Display/Image 3150 3150
Incorrect, Inadequate or Imprecise Resultor Readings 2851 2851
Defective Device 2847 2847
Battery Problem 2779 2779
Unable to Obtain Readings 2495 2495
Break 2386 2386
Defibrillation/Stimulation Problem 2330 2330
Failure to Charge 2302 2302
Therapeutic or Diagnostic Output Failure 2065 2065
Device Inoperable 1882 1882
Electrical /Electronic Property Problem 1719 1719
Unexpected Shutdown 1610 1610
Failure to Deliver Shock/Stimulation 1581 1581
Computer Operating System Problem 1400 1400
Appropriate Term/Code Not Available 1311 1311
Defective Component 1259 1259
Failure To Run On AC/DC 1090 1090
Power Problem 1060 1060
Loss of Power 1029 1029
Charging Problem 871 871
Detachment of Device or Device Component 706 706
Device Sensing Problem 700 700
Noise, Audible 695 695
Failure to Discharge 671 671
Output Problem 645 645
Display or Visual Feedback Problem 595 595
Failure to Deliver Energy 569 569
Pacing Problem 567 567
Connection Problem 559 559
Material Twisted/Bent 499 499
Protective Measures Problem 478 478
Failure to Sense 462 462
Reset Problem 462 462
Inappropriate/Inadequate Shock/Stimulation 427 427
Insufficient Information 371 371
Failure to Calibrate 363 363
Adverse Event Without Identified Device or Use Problem 357 357
No Audible Prompt/Feedback 350 350
Premature Discharge of Battery 337 337
Energy Output Problem 336 336
Inappropriate or Unexpected Reset 332 332
Device Operational Issue 331 331
Device Alarm System 316 316
Grounding Malfunction 289 289
Incorrect Interpretation of Signal 280 280
Naturally Worn 271 271
Component Missing 270 270
Failure to Analyze Signal 246 246
Mechanical Problem 240 240
Device Stops Intermittently 239 239
Output below Specifications 236 236
Communication or Transmission Problem 234 234
Bent 218 218
Calibration Problem 208 208
Intermittent Loss of Power 208 208
Unintended Power Up 205 205
Inaudible or Unclear Audible Prompt/Feedback 197 197
Use of Device Problem 185 185
Nonstandard Device 183 183
High impedance 163 163
Low Battery 155 155
Image Display Error/Artifact 151 151
Loose or Intermittent Connection 150 150
Poor Quality Image 135 135
Sparking 130 130
Failure to Deliver 126 126
Crack 123 123
Activation Problem 115 115
Device Maintenance Issue 113 113
No Audible Alarm 107 107
Failure to Shut Off 104 104
Material Split, Cut or Torn 104 104
No Device Output 99 99
Patient Device Interaction Problem 96 96
Erratic or Intermittent Display 95 95
Failure to Select Signal 95 95
Intermittent Continuity 93 93
Failure to Read Input Signal 86 86
Data Problem 85 85
Improper Alarm 84 84
Computer Software Problem 82 82
Signal Artifact/Noise 77 77
Detachment Of Device Component 70 70
Component Falling 65 65
Application Interface Becomes Non-Functional Or Program Exits Abnormally 63 63
Improper Device Output 58 58
Audible Prompt/Feedback Problem 58 58
Material Discolored 54 54
Torn Material 53 53
Failure to Capture 51 51
Mechanics Altered 50 50
Thermal Decomposition of Device 48 48
Physical Resistance/Sticking 47 47
Leak/Splash 45 45
Failure to Run on Battery 45 45

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 44844 44844
No Known Impact Or Consequence To Patient 29073 29073
No Clinical Signs, Symptoms or Conditions 8375 8375
No Consequences Or Impact To Patient 2600 2600
No Information 1725 1725
Insufficient Information 1166 1166
Death 950 950
Cardiac Arrest 244 246
Injury 116 116
Burn(s) 87 87
No Code Available 64 64
Ventricular Fibrillation 48 48
Shock from Patient Lead(s) 31 31
Cardiopulmonary Arrest 27 27
Burn, Thermal 22 22
Necrosis 21 21
Shock 18 18
Electric Shock 18 18
Ventricular Tachycardia 14 14
Skin Tears 14 14
Arrhythmia 13 13
Loss Of Pulse 12 12
Bradycardia 10 11
Partial thickness (Second Degree) Burn 10 10
Superficial (First Degree) Burn 10 10
Loss of consciousness 9 10
Atrial Fibrillation 9 9
Chest Pain 9 9
Asystole 9 9
Premature Labor 8 8
Tachycardia 8 9
Hemorrhage/Bleeding 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Skin Irritation 5 5
Fall 5 5
Myocardial Infarction 5 5
Inadequate Osseointegration 5 5
Patient Problem/Medical Problem 5 5
Complaint, Ill-Defined 4 4
Abrasion 4 4
Skin Discoloration 4 4
Therapeutic Effects, Unexpected 3 3
Low Blood Pressure/ Hypotension 3 3
Sudden Cardiac Death 3 3
Laceration(s) 3 3
Therapeutic Response, Decreased 3 3
Dizziness 2 2
Heart Failure 2 2
Brain Injury 2 2
Tissue Damage 2 2
Pain 2 2
Bone Fracture(s) 2 2
Head Injury 2 2
Contusion 2 2
Apnea 2 2
Bruise/Contusion 2 2
Stroke/CVA 2 2
Discomfort 2 2
Diabetic Ketoacidosis 2 2
Thromboembolism 2 2
Chemical Exposure 2 2
Full thickness (Third Degree) Burn 2 2
Choking 2 2
Diminished Pulse Pressure 2 2
Alteration In Body Temperature 2 2
Lead(s), Burn(s) From 2 2
Complete Heart Block 2 2
Vitrectomy 2 2
Extubate 2 2
Collapse 2 2
Unspecified Heart Problem 2 2
Erythema 2 2
Septic Shock 2 2
Thrombosis 2 2
Skin Erosion 2 2
Spinal Column Injury 1 1
Seizures, Grand-Mal 1 1
Skin Inflammation 1 1
Sweating 1 1
Palpitations 1 1
Irregular Pulse 1 1
Low Oxygen Saturation 1 1
Respiratory Acidosis 1 1
Respiratory Failure 1 1
Vessel Or Plaque, Device Embedded In 1 1
Exsanguination 1 1
Hypothermia 1 1
Irritation 1 1
Atrial Flutter 1 1
Atrial Tachycardia 1 1
Cardiomyopathy 1 1
Dyspnea 1 1
Non specific EKG/ECG Changes 1 1
Emotional Changes 1 1
Coma 1 1
Numbness 1 1
Osteopenia/ Osteoporosis 1 1
Sleep Dysfunction 1 1
Lethargy 1 2
Suicidal Ideation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardiac Science Corporation II Jul-03-2019
2 Cardiac Science Corporation II Mar-09-2016
3 ConMed Corporation II Mar-24-2018
4 Defibtech, LLC II Jun-17-2020
5 Leonhard Lang Medizintechnik GmbH I Sep-12-2017
6 Leonhard Lang Medizintechnik GmbH I Oct-14-2016
7 Philips Electronics North America Corporation II May-30-2018
8 Philips Electronics North America Corporation III Mar-13-2018
9 Philips Electronics North America Corporation II Jan-14-2018
10 Philips Electronics North America Corporation II Sep-19-2016
11 Philips Electronics North America Corporation II Jun-02-2016
12 Philips Electronics North America Corp. II Oct-18-2018
13 Philips Electronics North America Corp. II May-23-2018
14 Philips North America, LLC II Oct-23-2020
15 Philips North America, LLC II Aug-13-2020
16 Philips North America, LLC II May-28-2020
17 Philips North America, LLC II May-28-2020
18 Philips North America, LLC II May-27-2020
19 Philips North America, LLC II May-20-2020
20 Philips North America, LLC II May-20-2020
21 Philips North America, LLC II Mar-13-2020
22 Philips North America, LLC II Feb-21-2020
23 Philips North America, LLC II Dec-05-2019
24 Philips North America, LLC II Nov-19-2019
25 Philips North America, LLC II Sep-06-2019
26 Philips North America, LLC II Jul-05-2019
27 Philips North America, LLC I Feb-08-2018
28 Philips North America, LLC I Mar-24-2017
29 Philips North America LLC II Feb-19-2020
30 Philips North America LLC II Sep-20-2019
31 Philips North America LLC II Dec-13-2018
32 Physio-Control Inc I Feb-26-2019
33 Physio-Control, Inc. II Mar-09-2021
34 Physio-Control, Inc. II Jun-11-2020
35 Physio-Control, Inc. II Apr-01-2020
36 Physio-Control, Inc. II Jan-16-2020
37 Physio-Control, Inc. I Jan-11-2018
38 Physio-Control, Inc. I Dec-12-2017
39 Physio-Control, Inc. I Mar-03-2017
40 Physio-Control, Inc. I Feb-11-2017
41 Physio-Control, Inc. II Feb-07-2017
42 Physio-Control, Inc. II Dec-14-2016
43 Physio-Control, Inc. II Jun-29-2016
44 Physio-Control, Inc. II Jun-15-2016
45 ZOLL Medical Corporation II Jul-03-2019
46 ZOLL Medical Corporation II Mar-13-2018
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