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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 107
Crack 39
Hole in material 27
Device Issue 25
Melted 14
Device operates differently than expected 12
Other (for use when an appropriate device code cannot be identified) 11
Fitting problem 8
Split 8
Cut in material 7
Loose or intermittent connection 6
Tears, rips, holes in device, device material 6
Connection issue 5
Detachment of device component 4
Disconnection 3
Burn of device or device component 3
Circuit Failure 3
Overheating of device or device component 3
Material rigid or stiff 3
Material integrity issue 3
Use of Device Issue 3
Electrical wires, defective 2
Torn material 2
Failure of device to self-test 2
Foreign material present in device 2
Tube(s), splitting of 2
Stretched 1
Collapse 1
Component(s), broken 1
Heat 1
Break 1
Material torqued 1
Malfunction 1
Device damaged prior to use 1
Total Device Problems 318

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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