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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 Reviews
ManufacturerDecision
BIO-DETEK, INC.
  SUBSTANTIALLY EQUIVALENT 2
CARDIAC SCIENCE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
HEARTSINE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
HEARTSINE TECHNOLOGIES, LTD.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV
  SUBSTANTIALLY EQUIVALENT 1
ZOLL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

Premarket Approvals (PMA)
2015 2016 2017 2018 2019 2020
0 0 4 20 25 44

MDR Year MDR Reports MDR Events
2015 16131 16131
2016 17043 17043
2017 16536 16536
2018 16576 16576
2019 16858 16858
2020 11565 11565

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operates Differently Than Expected 17845 17845
Failure to Power Up 9267 9267
Device Displays Incorrect Message 8675 8675
Failure of Device to Self-Test 8528 8528
Self-Activation or Keying 4776 4776
No Display/Image 3296 3296
Defective Device 2675 2675
Battery Problem 2674 2674
Break 2609 2609
Device Inoperable 2555 2555
Failure to Charge 2507 2507
Battery 2343 2343
Incorrect, Inadequate or Imprecise Resultor Readings 2232 2232
Defibrillation/Stimulation Problem 2043 2043
Therapeutic or Diagnostic Output Failure 1573 1573
Computer Operating System Problem 1553 1553
Unable to Obtain Readings 1451 1451
Failure To Run On AC/DC 1350 1350
Electrical /Electronic Property Problem 1312 1312
Appropriate Term/Code Not Available 1285 1285
Unexpected Shutdown 1272 1272
Loss of Power 1270 1270
Failure to Deliver Shock/Stimulation 1249 1249
Pin 1199 1199
Power Problem 1047 1047
Speaker/Sounder 1027 1027
Defective Component 1011 1011
Charging Problem 997 997
Failure to Discharge 872 872
Switch, Push Button 801 801
Adverse Event Without Identified Device or Use Problem 753 753
Device Sensing Problem 746 746
Connection Problem 695 695
Noise, Audible 678 678
Cable, Electrical 657 657
Display 605 605
Power Module 598 598
Failure to Deliver Energy 598 598
Output Problem 548 548
Display or Visual Feedback Problem 542 542
Failure to Sense 530 530
Pacing Problem 528 528
Inappropriate/Inadequate Shock/Stimulation 443 443
Material Twisted/Bent 443 443
Reset Problem 414 414
Screen 414 414
Protective Measures Problem 402 402
Failure to Calibrate 390 390
Device Stops Intermittently 363 363
Insufficient Information 353 353
No Audible Prompt/Feedback 350 350
Inappropriate or Unexpected Reset 348 348
Premature Discharge of Battery 347 347
Connector 347 347
Device Operational Issue 336 336
Device Alarm System 324 324
Bent 304 304
Communication or Transmission Problem 301 301
Energy Output Problem 288 288
Failure to Analyze Signal 269 269
Incorrect Interpretation of Signal 265 265
Calibration Problem 255 255
Mechanical Problem 244 244
Pad 239 239
Naturally Worn 227 227
Grounding Malfunction 224 224
Component Missing 223 223
Knob 220 220
Low Battery 203 203
Loose or Intermittent Connection 198 198
Poor Quality Image 183 183
Power Supply 182 182
Nonstandard Device 178 178
Intermittent Loss of Power 177 177
Image Display Error/Artifact 176 176
Intermittent Continuity 170 170
Output below Specifications 169 169
Capacitor 153 153
Use of Device Problem 150 150
Failure to Deliver 147 147
Failure to Read Input Signal 139 139
Crack 138 138
Patient Lead 136 136
LED (Light Emitting Diode) 129 129
No Audible Alarm 127 127
Keypad 124 124
Device Maintenance Issue 123 123
Sparking 123 123
No Device Output 119 119
Failure to Shut Off 112 112
Signal Artifact/Noise 109 109
Failure to Select Signal 102 102
Erratic or Intermittent Display 99 99
Application Interface Becomes Non-Functional Or Program Exits Abnormally 98 98
Electrode 98 98
High impedance 97 97
Detachment Of Device Component 96 96
Port 95 95
Monitor 92 92
Inaudible or Unclear Audible Prompt/Feedback 90 90

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 53073 53073
No Known Impact Or Consequence To Patient 34120 34120
No Consequences Or Impact To Patient 3770 3770
No Information 1723 1723
Death 1089 1089
No Clinical Signs, Symptoms or Conditions 880 880
Cardiac Arrest 243 244
Injury 111 111
Insufficient Information 101 101
Burn(s) 76 76
No Code Available 65 65
Ventricular Fibrillation 53 53
Shock from Patient Lead(s) 32 32
Cardiopulmonary Arrest 24 24
Shock 23 23
Burn, Thermal 20 20
Electric Shock 17 17
Ventricular Tachycardia 17 17
Loss Of Pulse 14 14
Loss of consciousness 13 13
Atrial Fibrillation 12 12
Bradycardia 9 9
Chest Pain 9 9
Arrhythmia 9 9
Partial thickness (Second Degree) Burn 9 9
Superficial (First Degree) Burn 7 7
Inadequate Osseointegration 7 7
Skin Tears 7 7
Premature Labor 7 7
Complaint, Ill-Defined 7 7
Hemorrhage/Bleeding 7 7
Laceration(s) 6 6
Fall 6 6
Abrasion 6 6
Tachycardia 6 6
Skin Discoloration 6 6
Skin Irritation 5 5
Sudden Cardiac Death 5 5
Patient Problem/Medical Problem 5 5
Full thickness (Third Degree) Burn 4 4
Not Applicable 4 4
Myocardial Infarction 4 4
Extubate 4 4
Discomfort 4 4
Apnea 4 4
Bruise/Contusion 3 3
Bone Fracture(s) 3 3
Therapeutic Response, Decreased 3 3
Collapse 3 3
Coma 3 3
Respiratory Distress 3 3
Vitrectomy 3 3
Alteration In Body Temperature 2 2
Test Result 2 2
Thromboembolism 2 2
Respiratory Failure 2 2
Complete Heart Block 2 2
Choking 2 2
Chemical Exposure 2 2
Lead(s), Burn(s) From 2 2
Seizures 2 2
Septic Shock 2 2
Skin Erosion 2 2
Pain 2 2
Diabetic Ketoacidosis 2 2
Anxiety 2 2
Irritation 2 2
Heart Failure 2 2
Thrombosis 2 2
Tissue Damage 2 2
Head Injury 2 2
Low Blood Pressure/ Hypotension 2 2
Electrocution 2 2
Contusion 2 2
Stroke/CVA 2 2
Cardiomyopathy 1 1
Atrial Flutter 1 1
Atrial Tachycardia 1 1
Muscle Stimulation 1 1
Abdominal Pain 1 1
Emotional Changes 1 1
Erythema 1 1
Exsanguination 1 1
Fistula 1 1
Dyspnea 1 1
Non specific EKG/ECG Changes 1 1
Hypothermia 1 1
Hypoxia 1 1
Liver Laceration(s) 1 1
Muscle Spasm(s) 1 1
Hyperbilirubinemia 1 1
Brain Injury 1 1
Inadequate Pain Relief 1 1
Numbness 1 1
Skin Inflammation 1 1
Sweating 1 1
Pneumonia 1 1
Nerve Damage 1 1
Undesired Nerve Stimulation 1 1
Spinal Column Injury 1 1

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 Covidien LLC II Sep-02-2015
5 Defibtech, LLC II Jun-17-2020
6 Leonhard Lang Medizintechnik GmbH I Sep-12-2017
7 Leonhard Lang Medizintechnik GmbH I Oct-14-2016
8 Philips Electronics North America Corporation II May-30-2018
9 Philips Electronics North America Corporation III Mar-13-2018
10 Philips Electronics North America Corporation II Jan-14-2018
11 Philips Electronics North America Corporation II Sep-19-2016
12 Philips Electronics North America Corporation II Jun-02-2016
13 Philips Electronics North America Corporation II Nov-20-2015
14 Philips Electronics North America Corporation II Nov-13-2015
15 Philips Electronics North America Corporation II Aug-04-2015
16 Philips Electronics North America Corp. II Oct-18-2018
17 Philips Electronics North America Corp. II May-23-2018
18 Philips Medical Systems, Inc. II Nov-10-2015
19 Philips Medical Systems, Inc. II Nov-05-2015
20 Philips Medical Systems, Inc. II Nov-03-2015
21 Philips Medical Systems, Inc. II Jan-13-2015
22 Philips North America, LLC II Oct-23-2020
23 Philips North America, LLC II Aug-13-2020
24 Philips North America, LLC II May-28-2020
25 Philips North America, LLC II May-28-2020
26 Philips North America, LLC II May-27-2020
27 Philips North America, LLC II May-20-2020
28 Philips North America, LLC II May-20-2020
29 Philips North America, LLC II Mar-13-2020
30 Philips North America, LLC II Feb-21-2020
31 Philips North America, LLC II Dec-05-2019
32 Philips North America, LLC II Nov-19-2019
33 Philips North America, LLC II Sep-06-2019
34 Philips North America, LLC II Jul-05-2019
35 Philips North America, LLC I Feb-08-2018
36 Philips North America, LLC I Mar-24-2017
37 Philips North America LLC II Feb-19-2020
38 Philips North America LLC II Sep-20-2019
39 Philips North America LLC II Dec-13-2018
40 Physio-Control Inc I Feb-26-2019
41 Physio-Control, Inc. II Jun-11-2020
42 Physio-Control, Inc. II Apr-01-2020
43 Physio-Control, Inc. II Jan-16-2020
44 Physio-Control, Inc. I Jan-11-2018
45 Physio-Control, Inc. I Dec-12-2017
46 Physio-Control, Inc. I Mar-03-2017
47 Physio-Control, Inc. I Feb-11-2017
48 Physio-Control, Inc. II Feb-07-2017
49 Physio-Control, Inc. II Dec-14-2016
50 Physio-Control, Inc. II Jun-29-2016
51 Physio-Control, Inc. II Jun-15-2016
52 ZOLL Medical Corporation II Jul-03-2019
53 ZOLL Medical Corporation II Mar-13-2018
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