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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 8

MDR Year MDR Reports MDR Events
2016 17043 17043
2017 16536 16536
2018 16577 16577
2019 16859 16859
2020 16179 16179
2021 1078 1078

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operates Differently Than Expected 12625 12625
Failure to Power Up 8412 8412
Failure of Device to Self-Test 8116 8116
Device Displays Incorrect Message 6332 6332
Self-Activation or Keying 3412 3412
No Display/Image 3029 3029
Defective Device 2803 2803
Incorrect, Inadequate or Imprecise Resultor Readings 2693 2693
Battery Problem 2612 2612
Break 2356 2356
Failure to Charge 2211 2211
Defibrillation/Stimulation Problem 2085 2085
Therapeutic or Diagnostic Output Failure 2001 2001
Unable to Obtain Readings 2000 2000
Battery 1993 1993
Device Inoperable 1881 1881
Electrical /Electronic Property Problem 1495 1495
Unexpected Shutdown 1472 1472
Failure to Deliver Shock/Stimulation 1415 1415
Computer Operating System Problem 1397 1397
Appropriate Term/Code Not Available 1297 1297
Defective Component 1147 1147
Failure To Run On AC/DC 1090 1090
Loss of Power 1016 1016
Speaker/Sounder 1016 1016
Pin 1001 1001
Power Problem 945 945
Charging Problem 866 866
Device Sensing Problem 685 685
Failure to Discharge 670 670
Switch, Push Button 659 659
Noise, Audible 642 642
Output Problem 588 588
Power Module 578 578
Display or Visual Feedback Problem 575 575
Connection Problem 549 549
Cable, Electrical 546 546
Failure to Deliver Energy 544 544
Pacing Problem 510 510
Material Twisted/Bent 473 473
Protective Measures Problem 462 462
Display 447 447
Failure to Sense 437 437
Reset Problem 434 434
Inappropriate/Inadequate Shock/Stimulation 412 412
Insufficient Information 357 357
Adverse Event Without Identified Device or Use Problem 354 354
Failure to Calibrate 348 348
No Audible Prompt/Feedback 341 341
Detachment of Device or Device Component 332 332
Device Operational Issue 331 331
Screen 328 328
Inappropriate or Unexpected Reset 326 326
Premature Discharge of Battery 316 316
Device Alarm System 309 309
Energy Output Problem 296 296
Connector 274 274
Component Missing 265 265
Incorrect Interpretation of Signal 260 260
Grounding Malfunction 244 244
Failure to Analyze Signal 242 242
Device Stops Intermittently 239 239
Naturally Worn 233 233
Mechanical Problem 228 228
Communication or Transmission Problem 223 223
Bent 218 218
Calibration Problem 207 207
Intermittent Loss of Power 198 198
Output below Specifications 198 198
Knob 190 190
Nonstandard Device 175 175
Pad 169 169
Use of Device Problem 164 164
Low Battery 155 155
Power Supply 153 153
Capacitor 150 150
Loose or Intermittent Connection 144 144
Image Display Error/Artifact 142 142
High impedance 141 141
Poor Quality Image 133 133
Crack 121 121
Sparking 121 121
LED (Light Emitting Diode) 119 119
Failure to Deliver 116 116
Device Maintenance Issue 113 113
Patient Lead 111 111
Inaudible or Unclear Audible Prompt/Feedback 110 110
No Audible Alarm 106 106
Activation Problem 102 102
Failure to Shut Off 101 101
No Device Output 99 99
Keypad 98 98
Failure to Select Signal 95 95
Material Split, Cut or Torn 94 94
Erratic or Intermittent Display 93 93
Intermittent Continuity 92 92
Patient Device Interaction Problem 90 90
Failure to Read Input Signal 85 85
Improper Alarm 84 84
Computer Software Problem 81 81

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 44742 44742
No Known Impact Or Consequence To Patient 29073 29073
No Clinical Signs, Symptoms or Conditions 4437 4437
No Consequences Or Impact To Patient 2596 2596
No Information 1725 1725
Death 946 946
Insufficient Information 906 906
Cardiac Arrest 216 217
Injury 116 116
Burn(s) 83 83
No Code Available 64 64
Ventricular Fibrillation 44 44
Shock from Patient Lead(s) 29 29
Cardiopulmonary Arrest 27 27
Burn, Thermal 21 21
Electric Shock 16 16
Shock 16 16
Ventricular Tachycardia 14 14
Loss Of Pulse 12 12
Chest Pain 9 9
Atrial Fibrillation 9 9
Bradycardia 9 9
Loss of consciousness 9 9
Partial thickness (Second Degree) Burn 9 9
Superficial (First Degree) Burn 8 8
Arrhythmia 8 8
Premature Labor 8 8
Tachycardia 7 7
Skin Tears 7 7
Necrosis 6 6
Hemorrhage/Bleeding 6 6
Asystole 6 6
Patient Problem/Medical Problem 5 5
Inadequate Osseointegration 5 5
Myocardial Infarction 5 5
Skin Irritation 5 5
Fall 5 5
Skin Discoloration 4 4
Complaint, Ill-Defined 4 4
Therapeutic Response, Decreased 3 3
Low Blood Pressure/ Hypotension 3 3
Abrasion 3 3
Therapeutic Effects, Unexpected 3 3
Sudden Cardiac Death 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Unspecified Heart Problem 2 2
Lead(s), Burn(s) From 2 2
Complete Heart Block 2 2
Vitrectomy 2 2
Collapse 2 2
Thrombosis 2 2
Extubate 2 2
Skin Erosion 2 2
Septic Shock 2 2
Discomfort 2 2
Heart Failure 2 2
Brain Injury 2 2
Tissue Damage 2 2
Pain 2 2
Laceration(s) 2 2
Bone Fracture(s) 2 2
Head Injury 2 2
Apnea 2 2
Bruise/Contusion 2 2
Contusion 2 2
Stroke/CVA 2 2
Thromboembolism 2 2
Choking 2 2
Alteration In Body Temperature 2 2
Diabetic Ketoacidosis 2 2
Chemical Exposure 2 2
Full thickness (Third Degree) Burn 2 2
Device Embedded In Tissue or Plaque 1 1
Not Applicable 1 1
Blister 1 1
Vascular System (Circulation), Impaired 1 1
Diminished Pulse Pressure 1 1
Inadequate Pain Relief 1 1
Shaking/Tremors 1 1
Confusion/ Disorientation 1 1
Cusp Tear 1 1
Tissue Breakdown 1 1
Electrocution 1 1
Hyperbilirubinemia 1 1
Hypoxia 1 1
Pneumonia 1 1
Respiratory Distress 1 1
Seizures 1 1
Nerve Damage 1 1
Phosphene Visualization 1 1
Dizziness 1 1
Anxiety 1 1
Vessel Or Plaque, Device Embedded In 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

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 Jun-11-2020
34 Physio-Control, Inc. II Apr-01-2020
35 Physio-Control, Inc. II Jan-16-2020
36 Physio-Control, Inc. I Jan-11-2018
37 Physio-Control, Inc. I Dec-12-2017
38 Physio-Control, Inc. I Mar-03-2017
39 Physio-Control, Inc. I Feb-11-2017
40 Physio-Control, Inc. II Feb-07-2017
41 Physio-Control, Inc. II Dec-14-2016
42 Physio-Control, Inc. II Jun-29-2016
43 Physio-Control, Inc. II Jun-15-2016
44 ZOLL Medical Corporation II Jul-03-2019
45 ZOLL Medical Corporation II Mar-13-2018
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