Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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
52 41 19 24 27 23

MDR Year MDR Reports MDR Events
2020 16197 16197
2021 16300 16300
2022 14867 14867
2023 13766 13766
2024 15114 15114
2025 6438 6438

Device Problems MDRs with this Device Problem Events in those MDRs
Failure of Device to Self-Test 13764 13764
Failure to Power Up 10974 10974
Unable to Obtain Readings 9914 9914
Defibrillation/Stimulation Problem 4455 4455
Detachment of Device or Device Component 4115 4115
Electrical /Electronic Property Problem 3573 3573
No Display/Image 3479 3479
Unexpected Shutdown 3298 3298
Failure to Deliver Shock/Stimulation 3179 3179
Battery Problem 3003 3003
Incorrect, Inadequate or Imprecise Result or Readings 2080 2080
Failure to Charge 1571 1571
Power Problem 1281 1281
Therapeutic or Diagnostic Output Failure 1275 1275
Pacing Problem 1190 1190
Defective Device 937 937
Grounding Malfunction 898 898
Premature Discharge of Battery 754 754
Output Problem 747 747
Defective Component 692 692
Inaudible or Unclear Audible Prompt/Feedback 609 609
Break 597 597
Use of Device Problem 579 579
Failure to Sense 539 539
Key or Button Unresponsive/not Working 537 537
High impedance 535 535
No Audible Prompt/Feedback 526 526
Device Sensing Problem 506 506
Energy Output Problem 478 478
Reset Problem 452 452
Device Displays Incorrect Message 447 447
Inappropriate/Inadequate Shock/Stimulation 430 430
Display or Visual Feedback Problem 425 425
Mechanical Problem 406 406
Insufficient Information 401 401
Incorrect Interpretation of Signal 388 388
Audible Prompt/Feedback Problem 369 369
Protective Measures Problem 368 368
Failure to Deliver Energy 355 355
Computer Operating System Problem 350 350
Failure to Conduct 337 337
Noise, Audible 322 322
Output below Specifications 319 319
Intermittent Loss of Power 296 296
Connection Problem 292 292
Failure to Analyze Signal 290 290
Material Twisted/Bent 288 288
Failure to Run on Battery 283 283
Fracture 247 247
Device Alarm System 240 240

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 65809 65809
No Patient Involvement 9264 9264
Insufficient Information 3500 3500
No Known Impact Or Consequence To Patient 2026 2026
Cardiac Arrest 722 722
No Consequences Or Impact To Patient 487 487
Unspecified Heart Problem 335 335
No Information 244 244
Necrosis 225 225
Burn(s) 195 195
Death 167 167
Ventricular Fibrillation 122 122
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 99 99
Injury 56 56
Superficial (First Degree) Burn 44 44
Arrhythmia 41 41
Tachycardia 40 40
Asystole 36 36
Electric Shock 31 31
Atrial Fibrillation 28 28
Bradycardia 25 25
Skin Tears 24 24
Injection Site Reaction 21 21
Partial thickness (Second Degree) Burn 17 17
Shock from Patient Lead(s) 14 14
Myocardial Infarction 12 12
Erythema 10 10
Respiratory Arrest 10 10
Chest Pain 9 9
Heart Block 9 9
Low Blood Pressure/ Hypotension 8 8
Loss of consciousness 7 7
Burn, Thermal 7 7
Cardiopulmonary Arrest 6 6
Skin Discoloration 6 6
Shock 5 5
Diaphoresis 5 5
Blister 4 4
Inadequate Osseointegration 4 4
No Code Available 4 4
Therapeutic Effects, Unexpected 3 3
Abrasion 3 3
Asthma 3 3
Hemorrhage/Bleeding 3 3
Non specific EKG/ECG Changes 3 3
Numbness 3 3
Respiratory Failure 3 3
Stroke/CVA 3 3
Therapeutic Response, Decreased 3 3
Angina 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 May-14-2024
7 HeartSine Technologies Ltd II Feb-15-2024
8 HeartSine Technologies Ltd II Jul-13-2023
9 HeartSine Technologies Ltd II Mar-03-2023
10 Philips North America, LLC II Oct-23-2020
11 Philips North America, LLC II Aug-13-2020
12 Philips North America, LLC II May-28-2020
13 Philips North America, LLC II May-28-2020
14 Philips North America, LLC II May-27-2020
15 Philips North America, LLC II May-20-2020
16 Philips North America, LLC II May-20-2020
17 Philips North America, LLC II Mar-13-2020
18 Philips North America, LLC II Feb-21-2020
19 Philips North America LLC II Apr-06-2022
20 Philips North America LLC II Oct-08-2021
21 Philips North America LLC II Sep-03-2021
22 Philips North America LLC II Feb-19-2020
23 Physio-Control, Inc. II Feb-25-2025
24 Physio-Control, Inc. II Feb-19-2025
25 Physio-Control, Inc. II Oct-25-2024
26 Physio-Control, Inc. II Dec-15-2023
27 Physio-Control, Inc. II Nov-14-2023
28 Physio-Control, Inc. III Mar-10-2022
29 Physio-Control, Inc. II Mar-09-2021
30 Physio-Control, Inc. II Jun-11-2020
31 Physio-Control, Inc. II Apr-01-2020
32 Physio-Control, Inc. II Jan-16-2020
33 ZOLL Medical Corporation II Mar-12-2025
34 Zoll Medical Corporation II Jul-10-2024
-
-