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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 577
Prompts will not clear 529
Device operates differently than expected 292
Device stops intermittently 82
Battery issue 58
No display or display failure 51
Failure to power-up 39
No Known Device Problem 28
Low battery 23
Failure to deploy 22
Device Issue 10
Loss of power 8
Deployment issue 8
Charging issue 7
Connection issue 7
Device inoperable 7
Incorrect display 6
Erratic display 5
Break 5
Loose or intermittent connection 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
Poor quality image 2
No device output 2
Issue with displayed error message 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
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
Fitting problem 1
Retraction problem 1
Failure to sense 1
Inadequate storage 1
Malfunction 1
Arcing 1
Total Device Problems 1814

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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