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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)
2021 2022 2023 2024 2025 2026
41 19 24 27 48 17

MDR Year MDR Reports MDR Events
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 13619 13620
Failure to Power Up 11774 11774
Unable to Obtain Readings 9493 9493
Defibrillation/Stimulation Problem 4657 4657
Detachment of Device or Device Component 4524 4524
Unexpected Shutdown 3414 3414
No Display/Image 3391 3392
Failure to Deliver Shock/Stimulation 3360 3363
Electrical /Electronic Property Problem 3222 3222
Battery Problem 2592 2593
Premature Discharge of Battery 1821 1821
Pacing Problem 1231 1231
Failure to Charge 1189 1189
Power Problem 1114 1114
Grounding Malfunction 1001 1002
Material Deformation 824 824
Key or Button Unresponsive/not Working 691 691
Use of Device Problem 658 658
No Audible Prompt/Feedback 602 602
Incorrect, Inadequate or Imprecise Result or Readings 559 559
Inaudible or Unclear Audible Prompt/Feedback 557 557
Output Problem 550 550
Device Sensing Problem 541 541
Inappropriate/Inadequate Shock/Stimulation 489 489
Failure to Sense 474 474
Incorrect Interpretation of Signal 434 434
Mechanical Problem 429 429
High impedance 410 410
Reset Problem 409 409
Energy Output Problem 407 407
Audible Prompt/Feedback Problem 397 397
Insufficient Device Problem Information 364 364
Failure to Conduct 337 337
Display or Visual Feedback Problem 331 331
Failure to Run on Battery 321 321
Failure to Deliver Energy 304 304
Failure to Analyze Signal 301 301
Intermittent Loss of Power 295 295
Fracture 280 280
Patient Device Interaction Problem 279 279
Connection Problem 261 261
Output below Specifications 228 228
Sparking 219 219
Material Integrity Problem 205 205
Accessory Incompatible 194 194
Naturally Worn 192 192
Break 192 192
Activation Problem 191 191
Failure to Discharge 189 189
Device Alarm System 157 157

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 74197 74209
Insufficient Information 3309 3317
Cardiac Arrest 803 803
Unspecified Heart Problem 376 376
Necrosis 233 233
Burn(s) 226 226
Ventricular Fibrillation 138 138
No Patient Involvement 102 102
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 102 102
Superficial (First Degree) Burn 59 59
Intraoperative Cardiac Valve Injury 47 47
Asystole 43 43
Tachycardia 42 42
Arrhythmia 41 41
Atrial Fibrillation 32 32
Electric Shock 29 29
Bradycardia 28 28
Skin Tears 23 23
Injection Site Reaction 22 22
Partial thickness (Second Degree) Burn 21 21
Myocardial Infarction 13 13
Shock from Patient Lead(s) 12 12
Erythema 12 12
Heart Block 11 11
Chest Pain 11 11
Respiratory Arrest 10 10
Low Blood Pressure/ Hypotension 10 10
Death 10 10
Inadequate Osseointegration 9 9
Loss of consciousness 7 7
Skin Discoloration 7 7
Diaphoresis 5 5
Stroke/CVA 5 5
No Consequences Or Impact To Patient 4 4
Breath odor 3 3
Abrasion 3 3
Syncope/Fainting 3 3
Facial Paralysis 3 3
Asthma 3 3
Non specific EKG/ECG Changes 3 3
Respiratory Failure 3 3
Angina 3 3
Numbness 3 3
Bone Cement Implantation Syndrome 3 3
Blister 3 3
Unspecified Tissue Injury 2 2
Hemorrhage/Blood Loss/Bleeding 2 2
Sepsis 2 2
Subcutaneous Nodule 2 2
Atrial Flutter 2 2

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 HeartSine Technologies Ltd II Oct-23-2025
6 HeartSine Technologies Ltd II Jul-25-2025
7 HeartSine Technologies Ltd II May-14-2024
8 HeartSine Technologies Ltd II Feb-15-2024
9 HeartSine Technologies Ltd II Jul-13-2023
10 HeartSine Technologies Ltd II Mar-03-2023
11 Philips North America LLC II Apr-06-2022
12 Philips North America LLC II Oct-08-2021
13 Philips North America LLC II Sep-03-2021
14 Physio-Control, Inc. II May-04-2026
15 Physio-Control, Inc. II Mar-10-2026
16 Physio-Control, Inc. II Sep-02-2025
17 Physio-Control, Inc. II Feb-25-2025
18 Physio-Control, Inc. II Feb-19-2025
19 Physio-Control, Inc. II Oct-25-2024
20 Physio-Control, Inc. II Dec-15-2023
21 Physio-Control, Inc. II Nov-14-2023
22 Physio-Control, Inc. III Mar-10-2022
23 Physio-Control, Inc. II Mar-09-2021
24 ZOLL Medical Corporation II Mar-12-2025
25 Zoll Medical Corporation II Jul-10-2024
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