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TPLC
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show TPLC since
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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
1
ZOLL CIRCULATION, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
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
2861
2861
Use of Device Problem
661
661
Failure to Power Up
156
156
Unexpected Shutdown
124
124
Adverse Event Without Identified Device or Use Problem
117
117
Display or Visual Feedback Problem
110
110
No Display/Image
79
79
Display Difficult to Read
68
68
Material Integrity Problem
57
57
Battery Problem
55
55
Noise, Audible
48
48
Mechanical Problem
39
39
Material Split, Cut or Torn
37
37
Electrical /Electronic Property Problem
25
25
Retraction Problem
25
25
Power Problem
23
23
Fitting Problem
21
21
Break
19
19
Patient Device Interaction Problem
14
14
Fire
14
14
Material Twisted/Bent
10
10
Insufficient Information
9
9
Unexpected Therapeutic Results
9
9
Erratic or Intermittent Display
9
9
Intermittent Loss of Power
8
8
Output Problem
8
8
Physical Resistance/Sticking
8
8
Connection Problem
7
7
Therapeutic or Diagnostic Output Failure
7
7
Complete Loss of Power
6
6
Appropriate Term/Code Not Available
4
4
Failure to Run on Battery
4
4
Loose or Intermittent Connection
3
3
Defective Device
3
3
Sharp Edges
2
2
Detachment of Device or Device Component
2
2
Smoking
2
2
Intermittent Energy Output
2
2
Mechanical Jam
2
2
Difficult to Remove
2
2
Application Program Version or Upgrade Problem
2
2
Failure to Charge
2
2
Leak/Splash
2
2
Positioning Problem
1
1
Electrical Overstress
1
1
Product Quality Problem
1
1
Decoupling
1
1
Device Damaged Prior to Use
1
1
Unintended Electrical Shock
1
1
Material Separation
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
2253
2253
No Patient Involvement
710
710
Insufficient Information
649
649
No Consequences Or Impact To Patient
438
438
No Known Impact Or Consequence To Patient
59
59
Cardiac Arrest
42
42
Bone Fracture(s)
29
29
Hemorrhage/Bleeding
22
22
Laceration(s)
20
20
Death
19
19
Liver Laceration(s)
19
19
Injury
15
15
Unspecified Heart Problem
9
9
Multiple Fractures
9
9
Pleural Effusion
7
7
Abrasion
5
5
Bruise/Contusion
4
4
Pain
4
4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
4
4
Cardiac Perforation
3
3
Contusion
3
3
Rupture
3
3
Respiratory Arrest
3
3
Internal Organ Perforation
3
3
Burn(s)
2
2
Perforation
2
2
Cardiopulmonary Arrest
2
2
Pulmonary Edema
2
2
Sepsis
2
2
Spinal Column Injury
1
1
Aortic Dissection
1
1
Scar Tissue
1
1
Renal Impairment
1
1
Vascular System (Circulation), Impaired
1
1
Myocardial Infarction
1
1
No Code Available
1
1
Liver Damage/Dysfunction
1
1
Loss of consciousness
1
1
Paraplegia
1
1
Airway Obstruction
1
1
Full thickness (Third Degree) Burn
1
1
Tissue Breakdown
1
1
Pneumothorax
1
1
Pulmonary Embolism
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Defibtech, LLC
I
Aug-14-2024
2
ZOLL Circulation, Inc.
II
Oct-21-2022
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