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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
DEFIBTECH, LLC
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 4
MCKESSON
  SUBSTANTIALLY EQUIVALENT 1
MEDASONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL PRODUCTS.
  SUBSTANTIALLY EQUIVALENT 1
MICHIGAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 6
REVIVANT CORP.
  SUBSTANTIALLY EQUIVALENT 4
ZOLL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Device displays error message 777
Prompts will not clear 627
Device operates differently than expected 355
Device stops intermittently 98
Battery issue 87
No display or display failure 61
Failure to power-up 48
Low battery 41
No Known Device Problem 33
Failure to deploy 25
Device Issue 17
Deployment issue 15
Connection issue 10
Device inoperable 10
Loss of power 8
Charging issue 7
Incorrect display 6
Loose or intermittent connection 5
Erratic display 5
Break 5
Failure to charge 4
Not Applicable 4
Premature discharge of battery 3
Improper or incorrect procedure or method 3
Use of Device Issue 2
Failure to sense 2
Unknown (for use when the device problem is not known) 2
Poor quality image 2
No device output 2
Issue with displayed error message 2
Output below specifications 2
Power source issue 2
Therapeutic or diagnostic output failure 2
Detachment of device or device component 1
No Information 1
Device handling issue 1
Failure of device to self-test 1
Installation-related problem 1
Overheating of device or device component 1
Image display error 1
Battery failure 1
Bent 1
Crack 1
Difficult to deploy 1
Malfunction 1
Arcing 1
Fitting problem 1
Retraction problem 1
Inadequate storage 1
Total Device Problems 2288

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 1 0 0 0 0
Class III 0 0 0 0 2 0 0 1 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Jolife AB III Mar-16-2011
2 Zoll Circulation, Inc. III Jul-22-2014
3 Zoll Circulation, Inc. II Jan-09-2013
4 Zoll Circulation, Inc. III Apr-07-2011

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