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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device pump, portable, aspiration (manual or powered)
Regulation Description Powered suction pump.
Product CodeBTA
Regulation Number 878.4780
Device Class 2


Premarket Reviews
ManufacturerDecision
ALLIED HEALTHCARE PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
AMBU INTERNATIONAL A/S
  SUBSTANTIALLY EQUIVALENT 1
APPLIED MEDICAL RESOURCES CORP.
  SUBSTANTIALLY EQUIVALENT 1
ATMOS INC.
  SUBSTANTIALLY EQUIVALENT 2
ATRIUM MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
AVITA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BYRON MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 2
GENADYNE BIOTECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
GI SUPPLY
  SUBSTANTIALLY EQUIVALENT 1
HAEMONETICS CORP.
  SUBSTANTIALLY EQUIVALENT 2
I.C. MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
IMPACT INSTRUMENTATION, INC.
  SUBSTANTIALLY EQUIVALENT 3
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 2
LAERDAL MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 2
LIFE SUPPORT PRODUCTS
  SUBSTANTIALLY EQUIVALENT 2
MADA EQUIPMENT CO.
  SUBSTANTIALLY EQUIVALENT 1
MAQUET, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDELA
  SUBSTANTIALLY EQUIVALENT 11
MEDICAL INDUSTRIES AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERITS
  SUBSTANTIALLY EQUIVALENT 1
MICROAIRE
  SUBSTANTIALLY EQUIVALENT 1
NEOMEDIX CORP.
  SUBSTANTIALLY EQUIVALENT 1
NOUVAG AG
  SUBSTANTIALLY EQUIVALENT 1
Ohio Medical Corporation
  SUBSTANTIALLY EQUIVALENT 2
PENUMBRA, INC.
  SUBSTANTIALLY EQUIVALENT 1
PRECISION MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
SIMEX MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 1
SNYDER LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
STACKHOUSE
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
SUNRISE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
THE JOHN BUNN CO.
  SUBSTANTIALLY EQUIVALENT 1
XOMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZHONGSHAN A&E MACHINERY INDUSTRY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Crack 28
Burn of device or device component 19
Electrical issue 17
Device operates differently than expected 10
Break 8
Device Issue 7
Sticking 6
Suction issue 5
Mechanical issue 5
Decrease in pressure 3
Decrease in suction 3
Slippage of device or device component 3
Out-of-box failure 2
Aspiration issue 2
No Known Device Problem 2
Fire 2
Failure to charge 2
Fitting problem 2
Device inoperable 2
Use of Device Issue 1
Failure to osseointegrate 1
Other (for use when an appropriate device code cannot be identified) 1
Device damaged prior to use 1
Component missing 1
Difficult to remove 1
Failure to reset 1
Retraction problem 1
Occlusion within device 1
Device emits odor 1
Failure to power-up 1
Detachment of device component 1
Corrosion 1
Failure to run on AC/DC 1
Device alarm system issue 1
Bent 1
Blockage within device or device component 1
Fluid leak 1
Loose or intermittent connection 1
Cross connection 1
No Pressure 1
Positioning Issue 1
Pressure issue 1
Difficult to open or close 1
Foreign material present in device 1
Smoking 1
Defective item 1
Total Device Problems 155

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 3 0 2 0 0 0 0 0 1
Class III 0 1 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Neuromodulation II Sep-04-2008
2 MicroAire Surgical Instruments, LLC II Apr-05-2016
3 Neomedix Corp II Sep-29-2008
4 Ohio Medical Corporation II Dec-29-2010
5 Ohio Medical Corporation II Jun-07-2010
6 Smith And Nephew, Inc. Wound Management Division II Oct-27-2008
7 Smith And Nephew, Inc. Wound Management Division III Aug-06-2008

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