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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 44
Device operates differently than expected 24
Aspiration issue 23
Failure to pump 16
Suction issue 16
Device emits odor 14
Device clogged 14
Pressure issue 13
Spark 8
Electrical issue 8
Smoking 8
Pumping issue 7
Implant, removal of 6
Failure to power-up 6
Overheating of device or device component 5
Pumping stopped 5
Inappropriate shock 4
Component(s), broken 4
Cut in material 4
Device damaged prior to use 4
Device handling issue 4
Noise, Audible 4
Fluid leak 3
Leak 3
Mechanical issue 3
Device stops intermittently 3
Improper or incorrect procedure or method 2
Burn of device or device component 2
Occlusion within device 2
Melted 1
Misconnection 1
Loose 1
Incorrect measurement 1
Fracture 1
Excess flow or overinfusion 1
Detachment of device component 1
Decrease in suction 1
Disassembly 1
Filter, assembly 1
Fire 1
Failure to run on AC/DC 1
Air leak 1
Break 1
Fitting problem 1
Unknown (for use when the device problem is not known) 1
Device inoperable 1
Failure to zero 1
Incorrect or inadequate result 1
Material rigid or stiff 1
Pre or post-pumping problem 1
Decrease in pressure 1
Device contamination with blood or blood product 1
Connection issue 1
Low readings 1
Failure to obtain samples 1
Device displays error message 1
Sediment, precipitate or deposit in device or device ingredient 1
Improper flow or infusion 1
Material integrity issue 1
No Known Device Problem 1
Total Device Problems 290

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

Recalls
Manufacturer Recall Class Date Posted
1 DeVilbiss Healthcare LLC II Jul-20-2016
2 DeVilbiss Healthcare LLC II Oct-01-2013
3 EMG Technology Co., Ltd. II Sep-13-2014
4 Gardner Denver Thomas Inc II Jul-20-2015
5 Impact Instrumentation, Inc. III Sep-20-2012
6 KCI USA, Inc. II Sep-20-2008
7 Stryker Instruments Div. of Stryker Corporation II Aug-23-2016
8 Stryker Instruments Div. of Stryker Corporation II Jul-17-2015
9 Stryker Instruments Div. of Stryker Corporation II Jan-31-2014
10 Stryker Instruments Div. of Stryker Corporation II Dec-03-2012
11 Sunrise Medical II Feb-10-2009
12 Zeppessis Reprocessing, LLC II Sep-17-2013

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