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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device compressor, cardiac, external
Product CodeDRM
Regulation Number 870.5200
Device Class 2


Premarket Reviews
ManufacturerDecision
DEFIBTECH, LLC
  SUBSTANTIALLY EQUIVALENT 1
JOLIFE AB
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 783 783
2019 706 706
2020 844 844
2021 755 755
2022 730 730

Device Problems MDRs with this Device Problem Events in those MDRs
Visual Prompts will not Clear 2497 2497
Use of Device Problem 467 467
Device Displays Incorrect Message 288 288
Device Operational Issue 280 280
Failure to Power Up 164 164
Device Operates Differently Than Expected 94 94
Unexpected Shutdown 83 83
Display or Visual Feedback Problem 80 80
No Display/Image 75 75
Battery Problem 72 72
Adverse Event Without Identified Device or Use Problem 64 64
Display Difficult to Read 53 53
Material Integrity Problem 39 39
Device Issue 33 33
Noise, Audible 31 31
Material Split, Cut or Torn 28 28
Mechanical Problem 22 22
Power Problem 21 21
Retraction Problem 19 19
Low Battery 14 14
Electrical /Electronic Property Problem 13 13
Loss of Power 11 11
Fitting Problem 11 11
Device Stops Intermittently 10 10
Material Twisted/Bent 9 9
Connection Problem 9 9
Break 8 8
Erratic or Intermittent Display 7 7
Device Inoperable 7 7
Physical Resistance/Sticking 7 7
Patient Device Interaction Problem 7 7
Charging Problem 6 6
Failure to Run on Battery 6 6
Fire 6 6
Positioning Failure 5 5
Activation, Positioning or Separation Problem 5 5
Protective Measures Problem 5 5
Therapeutic or Diagnostic Output Failure 5 5
Intermittent Loss of Power 4 4
Failure to Charge 4 4
Overheating of Device 4 4
Loose or Intermittent Connection 3 3
Appropriate Term/Code Not Available 3 3
Complete Loss of Power 3 3
Output Problem 3 3
Mechanical Jam 2 2
Defective Device 2 2
Application Program Version or Upgrade Problem 2 2
Leak/Splash 2 2
Smoking 2 2
Unexpected Therapeutic Results 1 1
Product Quality Problem 1 1
Therapy Delivered to Incorrect Body Area 1 1
Improper or Incorrect Procedure or Method 1 1
Failure to Disconnect 1 1
Device Damaged Prior to Use 1 1
Energy Output Problem 1 1
Material Frayed 1 1
Computer Software Problem 1 1
Difficult or Delayed Positioning 1 1
Detachment of Device or Device Component 1 1
Positioning Problem 1 1
Failure to Shut Off 1 1
Inappropriate or Unexpected Reset 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1371 1371
No Patient Involvement 1128 1128
No Consequences Or Impact To Patient 473 473
Insufficient Information 378 378
No Known Impact Or Consequence To Patient 349 349
Death 35 35
Bone Fracture(s) 19 19
Injury 19 19
Heart Failure 18 18
Hemorrhage/Bleeding 14 14
Cardiac Arrest 13 13
Liver Laceration(s) 12 12
Laceration(s) 10 10
Abrasion 6 6
Multiple Fractures 5 5
Contusion 4 4
Pleural Effusion 4 4
Pain 3 3
Rupture 3 3
Cardiac Perforation 2 2
Not Applicable 2 2
No Information 2 2
Perforation 2 2
Pneumothorax 2 2
Pulmonary Embolism 2 2
Bruise/Contusion 2 2
Cardiopulmonary Arrest 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Hematoma 1 1
Airway Obstruction 1 1
Internal Organ Perforation 1 1
No Code Available 1 1
Full thickness (Third Degree) Burn 1 1
Tissue Breakdown 1 1
Patient Problem/Medical Problem 1 1
Vascular System (Circulation), Impaired 1 1
Loss of consciousness 1 1
Aortic Dissection 1 1
Excessive Tear Production 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Michigan Instruments, Inc. III May-04-2018
2 ZOLL Circulation, Inc. II Oct-21-2022
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