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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)
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)
2019 2020 2021 2022 2023 2024
25 52 41 19 24 16

MDR Year MDR Reports MDR Events
2019 16860 16860
2020 16197 16197
2021 16300 16300
2022 14867 14867
2023 13766 13766
2024 10424 10424

Device Problems MDRs with this Device Problem Events in those MDRs
Failure of Device to Self-Test 13398 13398
Failure to Power Up 11087 11087
Unable to Obtain Readings 8853 8853
Defibrillation/Stimulation Problem 4335 4335
Electrical /Electronic Property Problem 3763 3763
No Display/Image 3612 3612
Detachment of Device or Device Component 3481 3481
Unexpected Shutdown 3325 3325
Failure to Deliver Shock/Stimulation 3251 3251
Battery Problem 3219 3219
Incorrect, Inadequate or Imprecise Result or Readings 3195 3195
Therapeutic or Diagnostic Output Failure 2197 2197
Defective Device 2180 2180
Failure to Charge 1989 1989
Power Problem 1392 1392
Defective Component 1150 1150
Pacing Problem 1126 1126
Break 1039 1039
Output Problem 907 907
Grounding Malfunction 829 829
Device Displays Incorrect Message 819 819
Computer Operating System Problem 772 772
Display or Visual Feedback Problem 614 614
Failure to Sense 603 603
Inaudible or Unclear Audible Prompt/Feedback 587 587
Reset Problem 586 586
Protective Measures Problem 571 571
High impedance 534 534
Material Twisted/Bent 530 530
Energy Output Problem 528 528
Use of Device Problem 521 521
Noise, Audible 510 510
Device Sensing Problem 510 510
Inappropriate/Inadequate Shock/Stimulation 453 453
Failure to Deliver Energy 447 447
Appropriate Term/Code Not Available 423 423
No Audible Prompt/Feedback 408 408
Incorrect Interpretation of Signal 402 402
Insufficient Information 398 398
Key or Button Unresponsive/not Working 398 398
Charging Problem 371 371
Self-Activation or Keying 362 362
Connection Problem 356 356
Mechanical Problem 353 353
Output below Specifications 348 348
Failure to Conduct 333 333
Audible Prompt/Feedback Problem 332 332
Device Alarm System 325 325
Intermittent Loss of Power 318 318
Naturally Worn 299 299

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 55531 55531
No Patient Involvement 19242 19242
No Known Impact Or Consequence To Patient 7723 7723
Insufficient Information 3127 3127
No Consequences Or Impact To Patient 1102 1102
Cardiac Arrest 590 591
No Information 524 524
Death 370 370
Necrosis 225 225
Unspecified Heart Problem 218 218
Burn(s) 191 191
Injury 102 102
Ventricular Fibrillation 97 97
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 91 91
Arrhythmia 33 33
Asystole 33 33
Tachycardia 31 32
Superficial (First Degree) Burn 30 30
Electric Shock 28 28
Skin Tears 23 23
Atrial Fibrillation 23 23
Bradycardia 20 21
Shock from Patient Lead(s) 19 19
No Code Available 19 19
Injection Site Reaction 17 17
Cardiopulmonary Arrest 16 16
Partial thickness (Second Degree) Burn 15 15
Burn, Thermal 13 13
Myocardial Infarction 12 12
Loss of consciousness 10 11
Respiratory Arrest 10 10
Erythema 8 8
Chest Pain 7 7
Loss Of Pulse 7 7
Heart Block 6 6
Inadequate Osseointegration 6 6
Skin Discoloration 6 6
Shock 6 6
Abrasion 5 5
Low Blood Pressure/ Hypotension 5 5
Blister 4 4
Ventricular Tachycardia 4 4
Diaphoresis 4 4
Respiratory Failure 4 4
Non specific EKG/ECG Changes 4 4
Therapeutic Response, Decreased 3 3
Fall 3 3
Skin Irritation 3 3
Therapeutic Effects, Unexpected 3 3
Premature Labor 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Cardiac Science Corporation II Jul-03-2019
2 Defibtech, LLC II Mar-30-2023
3 Defibtech, LLC II Jun-17-2020
4 HeartSine Technologies Ltd II May-14-2024
5 HeartSine Technologies Ltd II Feb-15-2024
6 HeartSine Technologies Ltd II Jul-13-2023
7 HeartSine Technologies Ltd II Mar-03-2023
8 Philips North America, LLC II Oct-23-2020
9 Philips North America, LLC II Aug-13-2020
10 Philips North America, LLC II May-28-2020
11 Philips North America, LLC II May-28-2020
12 Philips North America, LLC II May-27-2020
13 Philips North America, LLC II May-20-2020
14 Philips North America, LLC II May-20-2020
15 Philips North America, LLC II Mar-13-2020
16 Philips North America, LLC II Feb-21-2020
17 Philips North America, LLC II Dec-05-2019
18 Philips North America, LLC II Nov-19-2019
19 Philips North America, LLC II Sep-06-2019
20 Philips North America, LLC II Jul-05-2019
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 Philips North America LLC II Sep-20-2019
26 Physio-Control Inc I Feb-26-2019
27 Physio-Control, Inc. II Dec-15-2023
28 Physio-Control, Inc. II Nov-14-2023
29 Physio-Control, Inc. III Mar-10-2022
30 Physio-Control, Inc. II Mar-09-2021
31 Physio-Control, Inc. II Jun-11-2020
32 Physio-Control, Inc. II Apr-01-2020
33 Physio-Control, Inc. II Jan-16-2020
34 ZOLL Medical Corporation II Jul-03-2019
35 Zoll Medical Corporation II Jul-10-2024
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