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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 400
Prompts will not clear 329
Device operates differently than expected 100
Device stops intermittently 70
Battery issue 41
No display or display failure 34
Failure to power-up 26
Failure to deploy 20
Low battery 18
No Known Device Problem 18
Loss of power 8
Incorrect display 6
Charging issue 6
Device inoperable 5
Device Issue 4
Connection issue 4
Deployment issue 4
Loose or intermittent connection 4
Erratic display 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
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
No Information 1
Device handling issue 1
Image display error 1
Battery failure 1
Retraction problem 1
Failure to sense 1
Bent 1
Crack 1
Difficult to deploy 1
Failure of device to self-test 1
Installation-related problem 1
Detachment of device or device component 1
Fitting problem 1
Malfunction 1
Arcing 1
Total Device Problems 1149

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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