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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)
2020 2021 2022 2023 2024 2025 2026
52 41 19 24 27 48 19

MDR Year MDR Reports MDR Events
2020 16197 16200
2021 16300 16315
2022 14867 14879
2023 13766 13767
2024 15108 15112
2025 13471 13471
2026 5945 5945

Device Problems MDRs with this Device Problem Events in those MDRs
Failure of Device to Self-Test 14157 14158
Failure to Power Up 13046 13046
Unable to Obtain Readings 10903 10903
Defibrillation/Stimulation Problem 5181 5181
Detachment of Device or Device Component 4773 4773
No Display/Image 3897 3898
Unexpected Shutdown 3871 3871
Electrical /Electronic Property Problem 3695 3695
Failure to Deliver Shock/Stimulation 3676 3679
Battery Problem 2626 2627
Premature Discharge of Battery 1829 1829
Pacing Problem 1368 1368
Failure to Charge 1300 1300
Power Problem 1232 1232
Grounding Malfunction 1091 1092
Material Deformation 824 824
Use of Device Problem 711 711
Key or Button Unresponsive/not Working 696 696
Output Problem 619 619
No Audible Prompt/Feedback 615 615
Device Sensing Problem 582 582
Failure to Sense 568 568
Inaudible or Unclear Audible Prompt/Feedback 566 566
Incorrect, Inadequate or Imprecise Result or Readings 563 563
Inappropriate/Inadequate Shock/Stimulation 542 542
High impedance 536 536
Reset Problem 503 503
Incorrect Interpretation of Signal 495 495
Energy Output Problem 440 440
Mechanical Problem 439 439
Audible Prompt/Feedback Problem 419 419
Failure to Deliver Energy 378 378
Insufficient Device Problem Information 372 372
Display or Visual Feedback Problem 368 368
Intermittent Loss of Power 340 340
Failure to Conduct 338 338
Failure to Analyze Signal 331 331
Failure to Run on Battery 322 322
Patient Device Interaction Problem 310 310
Connection Problem 290 290
Fracture 285 285
Output below Specifications 274 274
Activation Problem 251 251
Sparking 228 228
Defective Device 220 220
Material Integrity Problem 205 205
Accessory Incompatible 204 204
Break 193 193
Naturally Worn 192 192
Failure to Discharge 190 190

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 77928 77941
No Patient Involvement 9264 9265
Insufficient Information 4082 4090
No Known Impact Or Consequence To Patient 2026 2027
Cardiac Arrest 836 836
No Consequences Or Impact To Patient 487 487
Unspecified Heart Problem 378 378
Burn(s) 252 252
No Information 244 244
Necrosis 234 234
Death 167 167
Ventricular Fibrillation 148 148
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 105 105
Superficial (First Degree) Burn 59 59
Injury 56 56
Asystole 49 49
Intraoperative Cardiac Valve Injury 47 47
Arrhythmia 45 45
Tachycardia 43 43
Electric Shock 34 34
Atrial Fibrillation 33 33
Bradycardia 29 29
Skin Tears 26 26
Injection Site Reaction 22 22
Partial thickness (Second Degree) Burn 21 21
Myocardial Infarction 14 14
Shock from Patient Lead(s) 14 14
Erythema 12 12
Inadequate Osseointegration 11 11
Chest Pain 11 11
Heart Block 11 11
Low Blood Pressure/ Hypotension 10 10
Respiratory Arrest 10 10
Burn, Thermal 7 7
Skin Discoloration 7 7
Loss of consciousness 7 7
Cardiopulmonary Arrest 6 6
Stroke/CVA 5 5
Diaphoresis 5 5
Shock 5 5
Blister 4 4
No Code Available 4 4
Hemorrhage/Blood Loss/Bleeding 3 3
Angina 3 3
Numbness 3 3
Abrasion 3 3
Respiratory Failure 3 3
Therapeutic Effects, Unexpected 3 3
Asthma 3 3
Facial Paralysis 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Defibtech, LLC II Apr-29-2025
2 Defibtech, LLC II Apr-29-2025
3 Defibtech, LLC II Nov-25-2024
4 Defibtech, LLC II Mar-30-2023
5 Defibtech, LLC II Jun-17-2020
6 HeartSine Technologies Ltd II Oct-23-2025
7 HeartSine Technologies Ltd II Jul-25-2025
8 HeartSine Technologies Ltd II May-14-2024
9 HeartSine Technologies Ltd II Feb-15-2024
10 HeartSine Technologies Ltd II Jul-13-2023
11 HeartSine Technologies Ltd II Mar-03-2023
12 Philips North America, LLC II Oct-23-2020
13 Philips North America, LLC II Aug-13-2020
14 Philips North America, LLC II May-28-2020
15 Philips North America, LLC II May-28-2020
16 Philips North America, LLC II May-27-2020
17 Philips North America, LLC II May-20-2020
18 Philips North America, LLC II May-20-2020
19 Philips North America, LLC II Mar-13-2020
20 Philips North America, LLC II Feb-21-2020
21 Philips North America LLC II Apr-06-2022
22 Philips North America LLC II Oct-08-2021
23 Philips North America LLC II Sep-03-2021
24 Philips North America LLC II Feb-19-2020
25 Physio-Control, Inc. II May-04-2026
26 Physio-Control, Inc. II Mar-10-2026
27 Physio-Control, Inc. II Sep-02-2025
28 Physio-Control, Inc. II Feb-25-2025
29 Physio-Control, Inc. II Feb-19-2025
30 Physio-Control, Inc. II Oct-25-2024
31 Physio-Control, Inc. II Dec-15-2023
32 Physio-Control, Inc. II Nov-14-2023
33 Physio-Control, Inc. III Mar-10-2022
34 Physio-Control, Inc. II Mar-09-2021
35 Physio-Control, Inc. II Jun-11-2020
36 Physio-Control, Inc. II Apr-01-2020
37 Physio-Control, Inc. II Jan-16-2020
38 ZOLL Medical Corporation II Mar-12-2025
39 Zoll Medical Corporation II Jul-10-2024
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