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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device set, tubing and support, ventilator (w harness)
Regulation Description Ventilator tubing.
Product CodeBZO
Regulation Number 868.5975
Device Class 1


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
BIOVNA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
HAMILTON
  SUBSTANTIALLY EQUIVALENT 1
HUDSON RESPIRATORY CARE
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 1
NELLCOR PURITAN BENNETT
  SUBSTANTIALLY EQUIVALENT 1
RESPIRATORY SUPPORT PRODUCTS, INC. (RSP)
  SUBSTANTIALLY EQUIVALENT 2
SECHRIST INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS
  SUBSTANTIALLY EQUIVALENT 1
THORATEC CORP.
  SUBSTANTIALLY EQUIVALENT 1
Ventlab Corporation
  SUBSTANTIALLY EQUIVALENT 2
VITAL SIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Leak 110
Crack 48
Device Issue 32
Hole in material 27
Melted 14
Split 13
Device operates differently than expected 12
Other (for use when an appropriate device code cannot be identified) 11
Disconnection 9
Fitting problem 8
Connection issue 7
Cut in material 7
Tears, rips, holes in device, device material 6
Loose or intermittent connection 6
Detachment of device component 5
Overheating of device or device component 3
Material rigid or stiff 3
Burn of device or device component 3
Circuit Failure 3
Use of Device Issue 3
Material integrity issue 3
Failure of device to self-test 2
Foreign material present in device 2
Electrical wires, defective 2
Tube(s), splitting of 2
Break 2
Size incorrect for patient 2
Torn material 2
Device handling issue 1
Stretched 1
Blockage within device or device component 1
Heat 1
Collapse 1
Component(s), broken 1
Device damaged prior to use 1
Malfunction 1
Obstruction within device 1
Material torqued 1
Total Device Problems 357

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 1 1 0 0 0
Class II 0 0 0 0 0 0 0 1 1 0 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Draeger Medical, Inc. II Apr-10-2014
2 Fisher & Paykel Healthcare, Ltd. I May-20-2014
3 Fisher & Paykel Healthcare, Ltd. I Jan-03-2013
4 Hamilton Medical, Inc. II Jul-02-2015

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