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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 3


Premarket Reviews
ManufacturerDecision
DEFIBTECH, LLC
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 3
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 331
Prompts will not clear 285
Device operates differently than expected 85
Device stops intermittently 60
Battery issue 33
No display or display failure 29
Failure to power-up 20
Failure to deploy 19
Low battery 18
No Known Device Problem 18
Loss of power 8
Incorrect display 6
Charging issue 6
Device inoperable 5
Device Issue 4
Deployment issue 4
Loose or intermittent connection 4
Break 4
Not Applicable 4
Failure to charge 3
Premature discharge of battery 3
Improper or incorrect procedure or method 3
Use of Device Issue 2
Unknown (for use when the device problem is not known) 2
Connection issue 2
Erratic display 2
Poor quality image 2
Output below specifications 2
Power source issue 2
Therapeutic or diagnostic output failure 2
Issue with displayed error message 2
No Information 1
Device handling issue 1
Failure of device to self-test 1
Installation-related problem 1
Image display error 1
Battery failure 1
Retraction problem 1
Failure to sense 1
Bent 1
Crack 1
Difficult to deploy 1
Detachment of device or device component 1
Fitting problem 1
Malfunction 1
Arcing 1
Total Device Problems 985

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