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TPLC
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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
141
141
Device Problems
MDRs with this Device Problem
Events in those MDRs
Visual Prompts will not Clear
3761
3761
Device Displays Incorrect Message
1810
1810
Device Operational Issue
832
832
Use of Device Problem
648
648
Device Operates Differently Than Expected
630
630
Failure to Power Up
298
298
Battery Problem
215
215
No Display/Image
178
178
Adverse Event Without Identified Device or Use Problem
156
156
Device Stops Intermittently
127
127
Display or Visual Feedback Problem
114
114
Unexpected Shutdown
114
114
Device Inoperable
91
91
Break
85
85
Loss of Power
61
61
Display Difficult to Read
60
60
Low Battery
58
58
Noise, Audible
57
57
Device Issue
54
54
Material Integrity Problem
53
53
Mechanical Problem
42
42
Material Split, Cut or Torn
37
37
Retraction Problem
36
36
Positioning Failure
31
31
Charging Problem
31
31
Power Problem
30
30
Loose or Intermittent Connection
29
29
Fitting Problem
28
28
Connection Problem
28
28
Electrical /Electronic Property Problem
25
25
Activation, Positioning or Separation Problem
22
22
Component Missing
17
17
Crack
17
17
Failure to Charge
17
17
Device Alarm System
16
16
Erratic or Intermittent Display
16
16
Material Twisted/Bent
16
16
Insufficient Information
15
15
Patient Device Interaction Problem
14
14
Premature Discharge of Battery
14
14
Fire
14
14
Sticking
14
14
Component Falling
13
13
Defective Device
12
12
Therapeutic or Diagnostic Output Failure
9
9
Unexpected Therapeutic Results
9
9
Device Slipped
8
8
Defective Component
8
8
Physical Resistance/Sticking
8
8
Intermittent Loss of Power
8
8
Improper or Incorrect Procedure or Method
7
7
Image Display Error/Artifact
7
7
Detachment Of Device Component
6
6
Difficult to Remove
6
6
Overheating of Device
6
6
Failure to Run on Battery
6
6
Pumping Stopped
6
6
Protective Measures Problem
6
6
Positioning Problem
6
6
Output Problem
6
6
Complete Loss of Power
5
5
Material Separation
5
5
Material Frayed
4
4
No Apparent Adverse Event
4
4
Appropriate Term/Code Not Available
4
4
Malposition of Device
4
4
Detachment of Device or Device Component
3
3
Device Contamination with Body Fluid
3
3
Reset Problem
3
3
Leak/Splash
3
3
Poor Quality Image
3
3
Thermal Decomposition of Device
3
3
Bent
3
3
Contamination
3
3
Defibrillation/Stimulation Problem
3
3
Unable to Obtain Readings
3
3
Failure to Sense
2
2
Smoking
2
2
Unknown (for use when the device problem is not known)
2
2
Device Damaged Prior to Use
2
2
Material Too Rigid or Stiff
2
2
No Device Output
2
2
Difficult or Delayed Positioning
2
2
Torn Material
2
2
Optical Problem
2
2
Issue With Displayed Error Message
2
2
Intermittent Energy Output
2
2
Cut In Material
2
2
Failure to Align
2
2
Mechanical Jam
2
2
Device Dislodged or Dislocated
2
2
Moisture or Humidity Problem
2
2
Application Program Version or Upgrade Problem
2
2
Failure of Device to Self-Test
2
2
Failure to Shut Off
1
1
Inadequate Lighting
1
1
Inappropriate or Unexpected Reset
1
1
Installation-Related Problem
1
1
Device Sensing Problem
1
1
Naturally Worn
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Patient Involvement
2259
2259
No Clinical Signs, Symptoms or Conditions
2011
2011
No Known Impact Or Consequence To Patient
1392
1392
No Consequences Or Impact To Patient
777
777
Insufficient Information
579
579
Death
144
144
Cardiac Arrest
117
117
No Information
50
50
Bone Fracture(s)
41
41
Hemorrhage/Bleeding
30
30
Injury
29
29
Laceration(s)
24
24
Liver Laceration(s)
19
19
Heart Failure
18
18
Loss of consciousness
12
12
Multiple Fractures
9
9
Rupture
9
9
Abrasion
9
9
Cardiopulmonary Arrest
8
8
Patient Problem/Medical Problem
8
8
Unspecified Heart Problem
7
7
Pneumothorax
7
7
Internal Organ Perforation
7
7
Not Applicable
7
7
Pleural Effusion
7
7
Bruise/Contusion
6
6
Contusion
5
5
Tissue Damage
5
5
No Code Available
4
4
Pulmonary Embolism
4
4
Respiratory Distress
4
4
Cardiac Perforation
4
4
Sepsis
4
4
Dyspnea
4
4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
4
4
Pain
4
4
Loss Of Pulse
3
3
Vomiting
3
3
Perforation
3
3
Fall
3
3
Hematoma
3
3
Myocardial Infarction
3
3
Burn(s)
3
3
Respiratory Arrest
3
3
Complaint, Ill-Defined
2
2
Electrocution
2
2
Electric Shock
2
2
Respiratory Failure
2
2
Cardiac Tamponade
2
2
Ventricular Fibrillation
2
2
Paraplegia
1
1
Chest Pain
1
1
Stacking Breaths
1
1
Pneumonia
1
1
High Blood Pressure/ Hypertension
1
1
Abdominal Distention
1
1
Collapse
1
1
Liver Damage/Dysfunction
1
1
Apnea
1
1
Hemothorax
1
1
Tissue Breakdown
1
1
Full thickness (Third Degree) Burn
1
1
Airway Obstruction
1
1
Anemia
1
1
Perforation of Vessels
1
1
Palpitations
1
1
Excessive Tear Production
1
1
Spinal Column Injury
1
1
Cellulitis
1
1
Vascular System (Circulation), Impaired
1
1
Shock
1
1
Hyperemia
1
1
Swelling
1
1
Pulmonary Emphysema
1
1
Pallor
1
1
Aortic Dissection
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Jolife AB
III
Mar-16-2011
2
Michigan Instruments, Inc.
III
May-04-2018
3
ZOLL Circulation, Inc.
II
Oct-21-2022
4
Zoll Circulation, Inc.
III
Jul-22-2014
5
Zoll Circulation, Inc.
II
Jan-09-2013
6
Zoll Circulation, Inc.
III
Apr-07-2011
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