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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 45
Device emits odor 37
Device operates differently than expected 28
Aspiration issue 26
Smoking 22
Suction issue 19
Failure to pump 16
Device clogged 16
Pressure issue 15
Spark 11
Failure to power-up 11
Electrical issue 9
Overheating of device or device component 8
Pumping issue 8
Leak 7
Pumping stopped 6
Device handling issue 6
Implant, removal of 6
Noise, Audible 5
No code available 5
Fluid leak 5
Component(s), broken 4
Misconnection 4
Mechanical issue 4
Cut in material 4
Inappropriate shock 4
Device damaged prior to use 4
Device stops intermittently 3
Burn of device or device component 2
Incorrect measurement 2
Occlusion within device 2
Device contamination with blood or blood product 2
Improper or incorrect procedure or method 2
Connection issue 2
Improper flow or infusion 2
Material integrity issue 1
No Known Device Problem 1
Sediment, precipitate or deposit in device or device ingredient 1
Failure to shut off 1
Low readings 1
Failure to obtain samples 1
Device displays error message 1
Pre or post-pumping problem 1
Decrease in pressure 1
Fitting problem 1
Unknown (for use when the device problem is not known) 1
Melted 1
Device inoperable 1
Use of Device Issue 1
Failure to zero 1
Incorrect or inadequate result 1
Material rigid or stiff 1
Detachment of device component 1
Decrease in suction 1
Disassembly 1
Failure to run on AC/DC 1
Air leak 1
Device alarm system issue 1
Bleed back 1
Break 1
Fracture 1
Material frayed 1
Excess flow or overinfusion 1
Loose 1
Filter, assembly 1
Fire 1
Total Device Problems 383

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 1
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 Laerdal Medical Corporation II Apr-20-2017
8 Stryker Instruments Div. of Stryker Corporation II Aug-23-2016
9 Stryker Instruments Div. of Stryker Corporation II Jul-17-2015
10 Stryker Instruments Div. of Stryker Corporation II Jan-31-2014
11 Stryker Instruments Div. of Stryker Corporation II Dec-03-2012
12 Sunrise Medical II Feb-10-2009
13 Zeppessis Reprocessing, LLC II Sep-17-2013

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