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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
Regulation Description External cardiac compressor.
Product CodeDRM
Regulation Number 870.5200
Device Class 2


Premarket Reviews
ManufacturerDecision
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 2
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Visual Prompts will not Clear 1864
Device Displays Incorrect Message 1150
Device Operational Issue 832
Device Operates Differently Than Expected 479
Use of Device Problem 181
Battery Problem 164
Failure to Power Up 133
Device Stops Intermittently 111
No Display/Image 103
Adverse Event Without Identified Device or Use Problem 66
Low Battery 57
Device Issue 54
Display or Visual Feedback Problem 34
Positioning Failure 31
Activation, Positioning or SeparationProblem 22
Connection Problem 21
Display Difficult to Read 19
Unexpected Shutdown 19
Power Problem 17
Charging Problem 14
Material Split, Cut or Torn 12
Material Integrity Problem 12
Loss of Power 12
Device Inoperable 11
Erratic or Intermittent Display 9
Electrical /Electronic Property Problem 9
Failure to Charge 8
Loose or Intermittent Connection 7
Physical Resistance/Sticking 6
Patient Device Interaction Problem 6
Break 5
Fitting Problem 5
Mechanical Problem 4
Battery 4
Noise, Audible 4
Display 4
No Apparent Adverse Event 4
Protective Measures Problem 4
Overheating of Device 3
Retraction Problem 3
Failure to Run on Battery 3
Premature Discharge of Battery 3
Mechanical Jam 2
Therapeutic or Diagnostic Output Failure 2
Failure to Sense 2
Issue With Displayed Error Message 2
Leak/Splash 2
No Device Output 2
Difficult or Delayed Positioning 2
Poor Quality Image 2
Output Problem 1
Therapy Delivered to Incorrect Body Area 1
Detachment of Device or Device Component 1
Arcing 1
Belt 1
Device Component Or Accessory 1
Device Handling Problem 1
Image Display Error/Artifact 1
Material Twisted/Bent 1
Complete Loss of Power 1
Bent 1
Inadequate Storage 1
Inappropriate or Unexpected Reset 1
Crack 1
Installation-Related Problem 1
Physical Property Issue 1
Insufficient Information 1
Failure to Disconnect 1
Smoking 1
Panel 1
Screen 1
Failure of Device to Self-Test 1
Total Device Problems 5547

Recalls
Manufacturer Recall Class Date Posted
1 Michigan Instruments, Inc. III May-04-2018

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