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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device negative pressure wound therapy powered suction pump
Regulation Description Powered suction pump.
Definition For wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. The Device is indicated for management of chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.
Product CodeOMP
Regulation Number 878.4780
Device Class 2


Premarket Reviews
ManufacturerDecision
ARGENTUM MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
ATMOS INC.
  SUBSTANTIALLY EQUIVALENT 1
BLUE SKY MEDICAL
  SUBSTANTIALLY EQUIVALENT 4
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 1
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 3
GENADYNE BIOTECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 6
INNOVATIVE THERAPIES, INC.
  SUBSTANTIALLY EQUIVALENT 4
KINETIC CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 23
MEDELA
  SUBSTANTIALLY EQUIVALENT 6
MOLNLYCKE HEALTH CARE
  SUBSTANTIALLY EQUIVALENT 1
PREMCO MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SIMEX MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 2
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 16
TALLEY GROUP LTD.
  SUBSTANTIALLY EQUIVALENT 4

Device Problems
No Information 289
No Known Device Problem 78
No code available 40
Device alarm system issue 18
Suction issue 10
Device operates differently than expected 8
Leak 7
Burn of device or device component 6
Use of Device Issue 6
Difficult to remove 5
Power source issue 5
Not audible alarm 4
Device displays error message 4
Pressure issue 4
Blockage within device or device component 3
Air leak 3
Not Applicable 3
Improper or incorrect procedure or method 3
Device inoperable 3
Charging issue 2
Device contamination with blood or blood product 2
Loss of power 2
Device handling issue 2
Detachment of device component 2
Moisture or humidity problem 2
Entrapment of device or device component 2
Fluid leak 2
Detachment of device or device component 1
Crack 1
Blocked connection 1
Torn material 1
Noise, Audible 1
Charred 1
Other (for use when an appropriate device code cannot be identified) 1
Explode 1
Overheating of device or device component 1
Decrease in suction 1
Loose or intermittent connection 1
Markings, none 1
No Pressure 1
Foreign material present in device 1
Failure to power-up 1
Device emits odor 1
Device Issue 1
Hole in material 1
Pumping issue 1
Material rigid or stiff 1
Material discolored 1
Electronic property issue 1
Battery issue 1
Electro-static discharge 1
Patient-device incompatibility 1
Fire 1
Spark 1
Therapeutic or diagnostic output failure 1
Smoking 1
Failure to charge 1
Total Device Problems 545

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 3 0 2 0 6 0 2 0
Class III 0 0 2 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Accuro Medical Product LLC II Oct-04-2012
2 ConvaTec III Sep-29-2009
3 ConvaTec III Sep-09-2009
4 Convatec Inc. II Sep-28-2010
5 KCI USA, INC. II Jan-06-2016
6 KCI USA, INC. II Mar-05-2014
7 KCI USA, Inc. II Oct-15-2014
8 KCI USA, Inc. II Jan-25-2010
9 Smith & Nephew Inc. II Mar-10-2014
10 Smith & Nephew Inc. II Feb-21-2014
11 Smith & Nephew Inc. II Jan-26-2012
12 Smith & Nephew Inc. II Nov-03-2010
13 Smith & Nephew, Inc. II Sep-20-2016
14 Smith & Nephew, Inc. II Oct-08-2014
15 Smith & Nephew, Inc. II Sep-23-2014

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