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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 547
Prompts will not clear 414
Device operates differently than expected 212
Device stops intermittently 79
Battery issue 49
No display or display failure 44
Failure to power-up 38
No Known Device Problem 25
Failure to deploy 21
Low battery 20
Device Issue 9
Loss of power 8
Deployment issue 7
Charging issue 7
Device inoperable 6
Incorrect display 6
Break 5
Erratic display 4
Loose or intermittent connection 4
Connection issue 4
Not Applicable 4
Improper or incorrect procedure or method 3
Premature discharge of battery 3
Failure to charge 3
Poor quality image 2
No device output 2
Use of Device Issue 2
Unknown (for use when the device problem is not known) 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
Detachment of device or device component 1
Fitting problem 1
Malfunction 1
Arcing 1
Image display error 1
Battery failure 1
Retraction problem 1
Failure to sense 1
Crack 1
Difficult to deploy 1
Bent 1
Total Device Problems 1553

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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