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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 276
Prompts will not clear 238
Device operates differently than expected 78
Device stops intermittently 56
Battery issue 31
No display or display failure 23
Failure to deploy 19
Failure to power-up 18
No Known Device Problem 16
Low battery 10
Incorrect display 5
Charging issue 5
Device inoperable 5
Deployment issue 4
Not Applicable 4
Loose or intermittent connection 4
Loss of power 4
Device Issue 3
Break 3
Failure to charge 3
Premature discharge of battery 3
Improper or incorrect procedure or method 3
Issue with displayed error message 2
Power source issue 2
Output below specifications 2
Connection issue 2
Unknown (for use when the device problem is not known) 2
Therapeutic or diagnostic output failure 2
Erratic display 2
Poor quality image 2
Fitting problem 1
Arcing 1
Failure of device to self-test 1
Image display error 1
Installation-related problem 1
Malfunction 1
Crack 1
Detachment of device or device component 1
No Information 1
Retraction problem 1
Difficult to deploy 1
Battery failure 1
Bent 1
Failure to sense 1
Total Device Problems 841

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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