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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device compressor, cardiac, external
Product CodeDRM
Regulation Number 870.5200
Device Class 2


Premarket Reviews
ManufacturerDecision
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 208 208

Device Problems MDRs with this Device Problem Events in those MDRs
Visual Prompts will not Clear 3796 3796
Device Displays Incorrect Message 1810 1810
Device Operational Issue 832 832
Use of Device Problem 660 660
Device Operates Differently Than Expected 630 630
Failure to Power Up 299 299
Battery Problem 218 218
No Display/Image 178 178
Adverse Event Without Identified Device or Use Problem 157 157
Device Stops Intermittently 127 127
Unexpected Shutdown 119 119
Display or Visual Feedback Problem 116 116
Device Inoperable 91 91
Break 89 89
Display Difficult to Read 62 62
Loss of Power 61 61
Low Battery 58 58
Noise, Audible 57 57
Material Integrity Problem 56 56
Device Issue 54 54
Mechanical Problem 42 42
Material Split, Cut or Torn 37 37
Retraction Problem 36 36
Positioning Failure 31 31
Charging Problem 31 31
Connection Problem 31 31
Power Problem 30 30
Loose or Intermittent Connection 29 29
Fitting Problem 28 28
Electrical /Electronic Property Problem 25 25
Activation, Positioning or Separation Problem 22 22
Failure to Charge 18 18
Crack 17 17
Component Missing 17 17
Material Twisted/Bent 16 16
Erratic or Intermittent Display 16 16
Device Alarm System 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
Appropriate Term/Code Not Available 5 5
Complete Loss of Power 5 5
Material Separation 5 5
Material Frayed 4 4
No Apparent Adverse Event 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 2064 2064
No Known Impact Or Consequence To Patient 1392 1392
No Consequences Or Impact To Patient 777 777
Insufficient Information 595 595
Death 144 144
Cardiac Arrest 117 117
No Information 50 50
Bone Fracture(s) 41 41
Hemorrhage/Bleeding 31 31
Injury 29 29
Laceration(s) 24 24
Liver Laceration(s) 19 19
Heart Failure 18 18
Loss of consciousness 12 12
Rupture 9 9
Abrasion 9 9
Multiple Fractures 9 9
Unspecified Heart Problem 8 8
Cardiopulmonary Arrest 8 8
Patient Problem/Medical Problem 8 8
Not Applicable 7 7
Pneumothorax 7 7
Internal Organ Perforation 7 7
Pleural Effusion 7 7
Bruise/Contusion 6 6
Contusion 5 5
Tissue Damage 5 5
Respiratory Distress 4 4
Sepsis 4 4
No Code Available 4 4
Cardiac Perforation 4 4
Pain 4 4
Pulmonary Embolism 4 4
Dyspnea 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Respiratory Arrest 3 3
Burn(s) 3 3
Perforation 3 3
Myocardial Infarction 3 3
Fall 3 3
Hematoma 3 3
Loss Of Pulse 3 3
Vomiting 3 3
Complaint, Ill-Defined 2 2
Ventricular Fibrillation 2 2
Cardiac Tamponade 2 2
Electric Shock 2 2
Respiratory Failure 2 2
Electrocution 2 2
Pulmonary Emphysema 1 1
Cellulitis 1 1
Chest Pain 1 1
Stacking Breaths 1 1
Airway Obstruction 1 1
Anemia 1 1
Apnea 1 1
Hemothorax 1 1
Hyperemia 1 1
High Blood Pressure/ Hypertension 1 1
Liver Damage/Dysfunction 1 1
Pneumonia 1 1
Aortic Dissection 1 1
Collapse 1 1
Vascular System (Circulation), Impaired 1 1
Abdominal Distention 1 1
Full thickness (Third Degree) Burn 1 1
Tissue Breakdown 1 1
Excessive Tear Production 1 1
Shock 1 1
Spinal Column Injury 1 1
Swelling 1 1
Perforation of Vessels 1 1
Paraplegia 1 1
Palpitations 1 1
Pallor 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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