|
|
| 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 Code | MKJ |
| Regulation Number |
870.5310
|
|---|
| Device Class |
3
|
| Premarket Approvals (PMA) |
| 2019 |
2020 |
2021 |
2022 |
2023 |
2024 |
|
25
|
52
|
41
|
19
|
24
|
9
|
|
| MDR Year |
MDR Reports |
MDR Events |
| 2019 |
16860 |
16860 |
| 2020 |
16197 |
16197 |
| 2021 |
16300 |
16300 |
| 2022 |
14867 |
14867 |
| 2023 |
13766 |
13766 |
| 2024 |
5292 |
5292 |
|
| Patient Problems |
MDRs with this Patient Problem |
Events in those MDRs |
| No Clinical Signs, Symptoms or Conditions |
50691 |
50691 |
| No Patient Involvement |
19242 |
19242 |
| No Known Impact Or Consequence To Patient |
7723 |
7723 |
| Insufficient Information |
2997 |
2997 |
| No Consequences Or Impact To Patient |
1102 |
1102 |
| No Information |
524 |
524 |
| Cardiac Arrest |
504 |
505 |
| Death |
370 |
370 |
| Necrosis |
222 |
222 |
| Burn(s) |
179 |
179 |
| Unspecified Heart Problem |
164 |
164 |
| Injury |
102 |
102 |
| Ventricular Fibrillation |
82 |
82 |
| Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available |
80 |
80 |
| Superficial (First Degree) Burn |
29 |
29 |
| Tachycardia |
28 |
29 |
| Arrhythmia |
28 |
28 |
| Electric Shock |
27 |
27 |
| Asystole |
26 |
26 |
| Skin Tears |
22 |
22 |
| Atrial Fibrillation |
21 |
21 |
| No Code Available |
19 |
19 |
| Shock from Patient Lead(s) |
19 |
19 |
| Injection Site Reaction |
17 |
17 |
| Bradycardia |
17 |
18 |
| Cardiopulmonary Arrest |
16 |
16 |
| Partial thickness (Second Degree) Burn |
15 |
15 |
| Burn, Thermal |
13 |
13 |
| Loss of consciousness |
10 |
11 |
| Myocardial Infarction |
9 |
9 |
| Erythema |
8 |
8 |
| Loss Of Pulse |
7 |
7 |
| Respiratory Arrest |
7 |
7 |
| Inadequate Osseointegration |
6 |
6 |
| Chest Pain |
6 |
6 |
| Shock |
6 |
6 |
| Skin Discoloration |
6 |
6 |
| Ventricular Tachycardia |
4 |
4 |
| Non specific EKG/ECG Changes |
4 |
4 |
| Low Blood Pressure/ Hypotension |
4 |
4 |
| Abrasion |
4 |
4 |
| Respiratory Failure |
4 |
4 |
| Heart Block |
4 |
4 |
| Blister |
4 |
4 |
| Diaphoresis |
3 |
3 |
| Premature Labor |
3 |
3 |
| Fall |
3 |
3 |
| Therapeutic Response, Decreased |
3 |
3 |
| Skin Irritation |
3 |
3 |
| Therapeutic Effects, Unexpected |
3 |
3 |
| Skin Erosion |
2 |
2 |
| Laceration(s) |
2 |
2 |
| Pneumonia |
2 |
2 |
| Brain Injury |
2 |
2 |
| Numbness |
2 |
2 |
| Coma |
2 |
2 |
| Septic Shock |
2 |
2 |
| Complaint, Ill-Defined |
2 |
2 |
| Asthma |
2 |
2 |
| Stroke/CVA |
2 |
2 |
| Cardiomyopathy |
2 |
2 |
| Low Oxygen Saturation |
2 |
2 |
| Sudden Cardiac Death |
2 |
2 |
| Alteration In Body Temperature |
2 |
2 |
| Syncope/Fainting |
2 |
2 |
| Convulsion/Seizure |
2 |
2 |
| Diminished Pulse Pressure |
2 |
2 |
| Heart Failure/Congestive Heart Failure |
2 |
2 |
| Total Hearing Loss |
1 |
1 |
| Skin Disorders |
1 |
1 |
| Contact Dermatitis |
1 |
1 |
| Subcutaneous Nodule |
1 |
1 |
| Unspecified Tissue Injury |
1 |
1 |
| Fluid Discharge |
1 |
1 |
| Patient Problem/Medical Problem |
1 |
1 |
| Full thickness (Third Degree) Burn |
1 |
1 |
| Lead(s), Burn(s) From |
1 |
1 |
| Presyncope |
1 |
1 |
| Cancer |
1 |
1 |
| Suicidal Ideation |
1 |
1 |
| Cardiovascular Insufficiency |
1 |
1 |
| Vascular System (Circulation), Impaired |
1 |
1 |
| Confusion/ Disorientation |
1 |
1 |
| Lethargy |
1 |
2 |
| Shaking/Tremors |
1 |
1 |
| Decreased Respiratory Rate |
1 |
1 |
| Respiratory Acidosis |
1 |
1 |
| Irregular Pulse |
1 |
1 |
| Bruise/Contusion |
1 |
1 |
| Vessel Or Plaque, Device Embedded In |
1 |
1 |
| Atrial Flutter |
1 |
1 |
| Airway Obstruction |
1 |
1 |
| Anemia |
1 |
1 |
| Angina |
1 |
1 |
| Apnea |
1 |
1 |
| Bone Fracture(s) |
1 |
1 |
| Headache |
1 |
1 |
| Hemorrhage/Bleeding |
1 |
1 |
| Hyperbilirubinemia |
1 |
1 |
| Hypersensitivity/Allergic reaction |
1 |
1 |
|
| 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 |
Feb-15-2024 |
| 5 |
HeartSine Technologies Ltd |
II |
Jul-13-2023 |
| 6 |
HeartSine Technologies Ltd |
II |
Mar-03-2023 |
| 7 |
Philips North America, LLC |
II |
Oct-23-2020 |
| 8 |
Philips North America, LLC |
II |
Aug-13-2020 |
| 9 |
Philips North America, LLC |
II |
May-28-2020 |
| 10 |
Philips North America, LLC |
II |
May-28-2020 |
| 11 |
Philips North America, LLC |
II |
May-27-2020 |
| 12 |
Philips North America, LLC |
II |
May-20-2020 |
| 13 |
Philips North America, LLC |
II |
May-20-2020 |
| 14 |
Philips North America, LLC |
II |
Mar-13-2020 |
| 15 |
Philips North America, LLC |
II |
Feb-21-2020 |
| 16 |
Philips North America, LLC |
II |
Dec-05-2019 |
| 17 |
Philips North America, LLC |
II |
Nov-19-2019 |
| 18 |
Philips North America, LLC |
II |
Sep-06-2019 |
| 19 |
Philips North America, LLC |
II |
Jul-05-2019 |
| 20 |
Philips North America LLC |
II |
Apr-06-2022 |
| 21 |
Philips North America LLC |
II |
Oct-08-2021 |
| 22 |
Philips North America LLC |
II |
Sep-03-2021 |
| 23 |
Philips North America LLC |
II |
Feb-19-2020 |
| 24 |
Philips North America LLC |
II |
Sep-20-2019 |
| 25 |
Physio-Control Inc |
I |
Feb-26-2019 |
| 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 |
Jul-03-2019 |
|
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