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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device apparatus, suction, ward use, portable, ac-powered
Regulation Description Powered suction pump.
Product CodeJCX
Regulation Number 878.4780
Device Class 2


Premarket Reviews
ManufacturerDecision
AARDVARK MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 1
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 1
Ding Hwa Co., Ltd.
  SUBSTANTIALLY EQUIVALENT 3
EMG
  SUBSTANTIALLY EQUIVALENT 3
IMPACT INSTRUMENTATION, INC.
  SUBSTANTIALLY EQUIVALENT 5
KEYMED
  SUBSTANTIALLY EQUIVALENT 2
KINETIC CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
LAERDAL MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
PENUMBRA, INC.
  SUBSTANTIALLY EQUIVALENT 1
SCHUCO, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 2
SUNRISE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Pressure 21
Device clogged 14
Device emits odor 11
Electrical issue 7
Smoking 7
Implant, removal of 6
Suction issue 6
Aspiration issue 6
Device operates differently than expected 5
Pressure issue 5
Inappropriate shock 4
Cut in material 4
Component(s), broken 4
Overheating of device or device component 3
Leak 3
Spark 3
Pumping issue 3
Improper or incorrect procedure or method 2
Occlusion within device 2
Fluid leak 2
Fracture 1
Excess flow or overinfusion 1
Fitting problem 1
Unknown (for use when the device problem is not known) 1
Device damaged prior to use 1
Device stops intermittently 1
Failure to zero 1
Failure to obtain samples 1
Device displays error message 1
Loose 1
Incorrect measurement 1
Mechanical issue 1
Pre or post-pumping problem 1
Pumping stopped 1
Incorrect or inadequate result 1
Material rigid or stiff 1
Detachment of device component 1
Disassembly 1
Filter, assembly 1
Fire 1
Failure to run on AC/DC 1
Burn of device or device component 1
Sediment, precipitate or deposit in device or device ingredient 1
Noise, Audible 1
No Known Device Problem 1
Connection issue 1
Total Device Problems 144

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 1 1 0 0 1 2 2 2 0
Class III 0 0 0 0 0 1 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 DeVilbiss Healthcare LLC II Oct-01-2013
2 EMG Technology Co., Ltd. II Sep-13-2014
3 Gardner Denver Thomas Inc II Jul-20-2015
4 Impact Instrumentation, Inc. III Sep-20-2012
5 KCI USA, Inc. II Sep-20-2008
6 Stryker Instruments Div. of Stryker Corporation II Jul-17-2015
7 Stryker Instruments Div. of Stryker Corporation II Jan-31-2014
8 Stryker Instruments Div. of Stryker Corporation II Dec-03-2012
9 Sunrise Medical II Feb-10-2009
10 Zeppessis Reprocessing, LLC II Sep-17-2013

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