Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
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
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
compressor, cardiac, external
Product Code
DRM
Regulation Number
870.5200
Device Class
2
Premarket Reviews
Manufacturer
Decision
DEFIBTECH, LLC
SUBSTANTIALLY EQUIVALENT
2
JOLIFE AB
SUBSTANTIALLY EQUIVALENT
3
RESUSCITATION INTERNATIONAL
SUBSTANTIALLY EQUIVALENT
1
RESUSCITATION INTERNATIONAL, LLC
SUBSTANTIALLY EQUIVALENT
1
ZOLL CIRCULATION
SUBSTANTIALLY EQUIVALENT
1
ZOLL CIRCULATION, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
663
663
2015
674
674
2016
639
639
2017
679
679
2018
783
783
2019
706
706
2020
844
844
2021
755
755
2022
730
730
2023
765
765
2024
470
470
Device Problems
MDRs with this Device Problem
Events in those MDRs
Visual Prompts will not Clear
3935
3935
Device Displays Incorrect Message
1810
1810
Device Operational Issue
832
832
Use of Device Problem
713
713
Device Operates Differently Than Expected
630
630
Failure to Power Up
304
304
Battery Problem
235
235
No Display/Image
183
183
Adverse Event Without Identified Device or Use Problem
172
172
Device Stops Intermittently
127
127
Unexpected Shutdown
125
125
Display or Visual Feedback Problem
124
124
Device Inoperable
91
91
Break
90
90
Display Difficult to Read
69
69
Noise, Audible
62
62
Loss of Power
61
61
Low Battery
58
58
Material Integrity Problem
57
57
Device Issue
54
54
Mechanical Problem
42
42
Retraction Problem
39
39
Material Split, Cut or Torn
37
37
Connection Problem
32
32
Fitting Problem
32
32
Positioning Failure
31
31
Charging Problem
31
31
Power Problem
30
30
Loose or Intermittent Connection
30
30
Electrical /Electronic Property Problem
25
25
Activation, Positioning or Separation Problem
22
22
Insufficient Information
20
20
Failure to Charge
18
18
Component Missing
17
17
Crack
17
17
Erratic or Intermittent Display
16
16
Device Alarm System
16
16
Material Twisted/Bent
16
16
Premature Discharge of Battery
14
14
Sticking
14
14
Patient Device Interaction Problem
14
14
Fire
14
14
Component Falling
13
13
Defective Device
12
12
Therapeutic or Diagnostic Output Failure
9
9
Unexpected Therapeutic Results
9
9
Intermittent Loss of Power
8
8
Defective Component
8
8
Improper or Incorrect Procedure or Method
8
8
Difficult to Remove
8
8
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Patient Involvement
2259
2259
No Clinical Signs, Symptoms or Conditions
2256
2256
No Known Impact Or Consequence To Patient
1392
1392
No Consequences Or Impact To Patient
777
777
Insufficient Information
649
649
Death
144
144
Cardiac Arrest
122
122
No Information
50
50
Bone Fracture(s)
45
45
Hemorrhage/Bleeding
32
32
Injury
29
29
Laceration(s)
26
26
Liver Laceration(s)
21
21
Heart Failure
18
18
Loss of consciousness
12
12
Multiple Fractures
9
9
Unspecified Heart Problem
9
9
Rupture
9
9
Abrasion
9
9
Patient Problem/Medical Problem
8
8
Cardiopulmonary Arrest
8
8
Internal Organ Perforation
7
7
Not Applicable
7
7
Pneumothorax
7
7
Pleural Effusion
7
7
Bruise/Contusion
6
6
Tissue Damage
5
5
Contusion
5
5
No Code Available
4
4
Respiratory Distress
4
4
Sepsis
4
4
Pulmonary Embolism
4
4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
4
4
Pain
4
4
Cardiac Perforation
4
4
Dyspnea
4
4
Respiratory Arrest
3
3
Hematoma
3
3
Perforation
3
3
Myocardial Infarction
3
3
Fall
3
3
Loss Of Pulse
3
3
Burn(s)
3
3
Vomiting
3
3
Respiratory Failure
2
2
Pulmonary Edema
2
2
Electrocution
2
2
Ventricular Fibrillation
2
2
Cardiac Tamponade
2
2
Spinal Column Injury
2
2
Recalls
Manufacturer
Recall Class
Date Posted
1
Defibtech, LLC
I
Aug-14-2024
2
Jolife AB
III
Mar-16-2011
3
Michigan Instruments, Inc.
III
May-04-2018
4
ZOLL Circulation, Inc.
II
Oct-21-2022
5
Zoll Circulation, Inc.
III
Jul-22-2014
6
Zoll Circulation, Inc.
II
Jan-09-2013
7
Zoll Circulation, Inc.
III
Apr-07-2011
-
-