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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
141
141
Device Problems
MDRs with this Device Problem
Events in those MDRs
Visual Prompts will not Clear
2687
2687
Use of Device Problem
596
596
Failure to Power Up
150
150
Unexpected Shutdown
113
113
Adverse Event Without Identified Device or Use Problem
101
101
Display or Visual Feedback Problem
100
100
No Display/Image
74
74
Display Difficult to Read
59
59
Material Integrity Problem
53
53
Noise, Audible
43
43
Mechanical Problem
39
39
Material Split, Cut or Torn
37
37
Battery Problem
35
35
Electrical /Electronic Property Problem
25
25
Power Problem
23
23
Retraction Problem
22
22
Fitting Problem
17
17
Fire
14
14
Break
14
14
Patient Device Interaction Problem
14
14
Material Twisted/Bent
10
10
Erratic or Intermittent Display
9
9
Unexpected Therapeutic Results
9
9
Physical Resistance/Sticking
8
8
Intermittent Loss of Power
8
8
Therapeutic or Diagnostic Output Failure
7
7
Output Problem
6
6
Complete Loss of Power
5
5
Insufficient Information
4
4
Failure to Run on Battery
4
4
Defective Device
3
3
Connection Problem
3
3
Appropriate Term/Code Not Available
3
3
Mechanical Jam
2
2
Intermittent Energy Output
2
2
Detachment of Device or Device Component
2
2
Application Program Version or Upgrade Problem
2
2
Smoking
2
2
Leak/Splash
2
2
Loose or Intermittent Connection
2
2
Energy Output Problem
1
1
Overheating of Device
1
1
Loss of Power
1
1
Device Difficult to Setup or Prepare
1
1
Product Quality Problem
1
1
Failure to Charge
1
1
Computer Software Problem
1
1
Material Frayed
1
1
Device Damaged Prior to Use
1
1
Charging Problem
1
1
Electrical Overstress
1
1
Inappropriate or Unexpected Reset
1
1
Positioning Problem
1
1
Protective Measures Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
2008
2008
No Patient Involvement
710
710
Insufficient Information
579
579
No Consequences Or Impact To Patient
438
438
No Known Impact Or Consequence To Patient
59
59
Cardiac Arrest
37
37
Bone Fracture(s)
25
25
Hemorrhage/Bleeding
20
20
Death
19
19
Laceration(s)
18
18
Liver Laceration(s)
17
17
Injury
15
15
Multiple Fractures
9
9
Unspecified Heart Problem
7
7
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
Respiratory Arrest
3
3
Rupture
3
3
Cardiac Perforation
3
3
Contusion
3
3
Internal Organ Perforation
3
3
Cardiopulmonary Arrest
2
2
Burn(s)
2
2
Perforation
2
2
Sepsis
2
2
Pneumothorax
1
1
Loss of consciousness
1
1
Paraplegia
1
1
Aortic Dissection
1
1
Vascular System (Circulation), Impaired
1
1
Full thickness (Third Degree) Burn
1
1
No Code Available
1
1
Tissue Breakdown
1
1
Airway Obstruction
1
1
Pulmonary Embolism
1
1
Myocardial Infarction
1
1
Liver Damage/Dysfunction
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
ZOLL Circulation, Inc.
II
Oct-21-2022
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