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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 37

MDR Year MDR Reports MDR Events
2016 17063 17063
2017 16681 16681
2018 16586 16586
2019 16859 16859
2020 16196 16196
2021 10657 10657

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operates Differently Than Expected 12626 12626
Failure of Device to Self-Test 9767 9767
Failure to Power Up 9350 9350
Device Displays Incorrect Message 6345 6345
Self-Activation or Keying 3443 3443
No Display/Image 3386 3386
Unable to Obtain Readings 3320 3320
Battery Problem 2995 2995
Incorrect, Inadequate or Imprecise Resultor Readings 2939 2939
Defective Device 2875 2875
Defibrillation/Stimulation Problem 2650 2650
Break 2395 2395
Failure to Charge 2393 2393
Therapeutic or Diagnostic Output Failure 2096 2096
Electrical /Electronic Property Problem 2066 2066
Device Inoperable 1882 1882
Unexpected Shutdown 1815 1815
Failure to Deliver Shock/Stimulation 1798 1798
Computer Operating System Problem 1403 1403
Appropriate Term/Code Not Available 1312 1312
Defective Component 1290 1290
Power Problem 1224 1224
Failure To Run On AC/DC 1090 1090
Loss of Power 1030 1030
Charging Problem 885 885
Detachment of Device or Device Component 877 877
Device Sensing Problem 722 722
Noise, Audible 712 712
Output Problem 706 706
Failure to Discharge 686 686
Pacing Problem 651 651
Display or Visual Feedback Problem 622 622
Failure to Deliver Energy 600 600
Connection Problem 569 569
Protective Measures Problem 532 532
Material Twisted/Bent 528 528
Reset Problem 495 495
Failure to Sense 494 494
Inappropriate/Inadequate Shock/Stimulation 441 441
Insufficient Information 390 390
Failure to Calibrate 388 388
Energy Output Problem 370 370
No Audible Prompt/Feedback 367 367
Adverse Event Without Identified Device or Use Problem 362 362
Premature Discharge of Battery 350 350
Grounding Malfunction 344 344
Inappropriate or Unexpected Reset 337 337
Device Operational Issue 331 331
Device Alarm System 321 321
Incorrect Interpretation of Signal 298 298
Naturally Worn 293 293
Inaudible or Unclear Audible Prompt/Feedback 277 277
Output below Specifications 276 276
Component Missing 271 271
Failure to Analyze Signal 266 266
Mechanical Problem 254 254
Device Stops Intermittently 239 239
Communication or Transmission Problem 236 236
Intermittent Loss of Power 231 231
Use of Device Problem 220 220
Bent 218 218
High impedance 217 217
Unintended Power Up 212 212
Calibration Problem 210 210
Nonstandard Device 183 183
Loose or Intermittent Connection 165 165
Low Battery 155 155
Image Display Error/Artifact 154 154
Sparking 142 142
Poor Quality Image 139 139
Activation Problem 132 132
Failure to Deliver 126 126
Crack 126 126
Patient Device Interaction Problem 113 113
Material Split, Cut or Torn 113 113
Device Maintenance Issue 113 113
Failure to Shut Off 109 109
No Audible Alarm 107 107
No Device Output 99 99
Erratic or Intermittent Display 98 98
Failure to Read Input Signal 95 95
Failure to Select Signal 95 95
Intermittent Continuity 93 93
Data Problem 87 87
Computer Software Problem 85 85
Improper Alarm 84 84
Audible Prompt/Feedback Problem 84 84
Signal Artifact/Noise 84 84
Detachment Of Device Component 70 70
Component Falling 65 65
Application Interface Becomes Non-Functional Or Program Exits Abnormally 63 63
Failure to Run on Battery 60 60
Failure to Capture 59 59
Improper Device Output 58 58
Fracture 58 58
Material Discolored 56 56
Accessory Incompatible 54 54
Mechanics Altered 53 53
Torn Material 53 53
Physical Resistance/Sticking 49 49

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 44844 44844
No Known Impact Or Consequence To Patient 29073 29073
No Clinical Signs, Symptoms or Conditions 13676 13676
No Consequences Or Impact To Patient 2600 2600
No Information 1725 1725
Insufficient Information 1396 1396
Death 950 950
Cardiac Arrest 289 291
Injury 116 116
Burn(s) 97 97
No Code Available 64 64
Ventricular Fibrillation 53 53
Necrosis 38 38
Shock from Patient Lead(s) 31 31
Cardiopulmonary Arrest 27 27
Burn, Thermal 22 22
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 20 20
Electric Shock 19 19
Shock 18 18
Arrhythmia 16 16
Skin Tears 15 15
Ventricular Tachycardia 14 14
Superficial (First Degree) Burn 13 13
Loss Of Pulse 12 12
Asystole 11 11
Bradycardia 11 12
Tachycardia 10 11
Partial thickness (Second Degree) Burn 10 10
Loss of consciousness 9 10
Atrial Fibrillation 9 9
Chest Pain 9 9
Premature Labor 8 8
Hemorrhage/Bleeding 6 6
Fall 6 6
Skin Discoloration 5 5
Skin Irritation 5 5
Myocardial Infarction 5 5
Inadequate Osseointegration 5 5
Patient Problem/Medical Problem 5 5
Complaint, Ill-Defined 4 4
Abrasion 4 4
Low Blood Pressure/ Hypotension 3 3
Therapeutic Effects, Unexpected 3 3
Sudden Cardiac Death 3 3
Unspecified Heart Problem 3 3
Discomfort 3 3
Therapeutic Response, Decreased 3 3
Laceration(s) 3 3
Bone Fracture(s) 2 2
Head Injury 2 2
Pain 2 2
Tissue Damage 2 2
Dizziness 2 2
Heart Failure 2 2
Brain Injury 2 2
Contusion 2 2
Apnea 2 2
Bruise/Contusion 2 2
Stroke/CVA 2 2
Diabetic Ketoacidosis 2 2
Chemical Exposure 2 2
Choking 2 2
Diminished Pulse Pressure 2 2
Full thickness (Third Degree) Burn 2 2
Thromboembolism 2 2
Alteration In Body Temperature 2 2
Respiratory Failure 2 2
Lead(s), Burn(s) From 2 2
Complete Heart Block 2 2
Vitrectomy 2 2
Thrombosis 2 2
Skin Erosion 2 2
Extubate 2 2
Collapse 2 2
Erythema 2 2
Septic Shock 2 2
Vessel Or Plaque, Device Embedded In 1 1
Exsanguination 1 1
Hypothermia 1 1
Irritation 1 1
Rash 1 1
Atrial Flutter 1 1
Atrial Tachycardia 1 1
Cardiomyopathy 1 1
Dyspnea 1 1
Non specific EKG/ECG Changes 1 1
Emotional Changes 1 1
Coma 1 1
Numbness 1 1
Skin Inflammation 1 1
Sweating 1 1
Palpitations 1 1
Irregular Pulse 1 1
Low Oxygen Saturation 1 1
Respiratory Acidosis 1 1
Spinal Column Injury 1 1
Seizures, Grand-Mal 1 1
Osteopenia/ Osteoporosis 1 1
Sleep Dysfunction 1 1
Lethargy 1 2

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 Sep-03-2021
30 Philips North America LLC II Feb-19-2020
31 Philips North America LLC II Sep-20-2019
32 Philips North America LLC II Dec-13-2018
33 Physio-Control Inc I Feb-26-2019
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 Physio-Control, Inc. I Jan-11-2018
39 Physio-Control, Inc. I Dec-12-2017
40 Physio-Control, Inc. I Mar-03-2017
41 Physio-Control, Inc. I Feb-11-2017
42 Physio-Control, Inc. II Feb-07-2017
43 Physio-Control, Inc. II Dec-14-2016
44 Physio-Control, Inc. II Jun-29-2016
45 Physio-Control, Inc. II Jun-15-2016
46 ZOLL Medical Corporation II Jul-03-2019
47 ZOLL Medical Corporation II Mar-13-2018
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