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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device humidifier, respiratory gas, (direct patient interface)
Regulation Description Respiratory gas humidifier.
Product CodeBTT
Regulation Number 868.5450
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 2
ABBOTT
  SUBSTANTIALLY EQUIVALENT 3
ALLIED HEALTHCARE PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
AMERICAN BANTEX CORP
  SUBSTANTIALLY EQUIVALENT 1
BEAR MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 4
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 2
DRAEGER MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
FISHER & PAYKEL HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 14
HAMILTON
  SUBSTANTIALLY EQUIVALENT 1
HUDSON RESPIRATORY CARE
  SUBSTANTIALLY EQUIVALENT 5
INVACARE CORP.
  SUBSTANTIALLY EQUIVALENT 2
KING SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
MALLINCKRODT
  SUBSTANTIALLY EQUIVALENT 1
MARQUEST MEDICAL PRODUCTS INC
  SUBSTANTIALLY EQUIVALENT 4
MEDICAL INDUSTRIES AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDISIZE BV
  SUBSTANTIALLY EQUIVALENT 3
NELLCOR PURITAN BENNETT
  SUBSTANTIALLY EQUIVALENT 2
PACIFIC MEDICO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
PRECISION MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
RESMED
  SUBSTANTIALLY EQUIVALENT 2
RESPIRATORY SUPPORT PRODUCTS, INC. (RSP)
  SUBSTANTIALLY EQUIVALENT 2
RESPIRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 4
SMITHS
  SUBSTANTIALLY EQUIVALENT 3
SUNRISE MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 5
THE JOHN BUNN CO.
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 6
VAPOTHERM
  SUBSTANTIALLY EQUIVALENT 7
Ventlab Corporation
  SUBSTANTIALLY EQUIVALENT 1
VITAL SIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Power source issue 208
Connection issue 168
Failure to power-up 167
Leak 117
Temperature issue 97
Not audible alarm 96
Device operates differently than expected 92
Insufficient heating 78
Device alarm system issue 68
Crack 46
Overheating of device or device component 46
Detachment of device component 40
Other (for use when an appropriate device code cannot be identified) 33
Break 24
Melted 23
Device Issue 23
Burn of device or device component 21
Component missing 19
Device stops intermittently 18
Air leak 18
Disconnection 17
Fitting problem 16
Tear, rip or hole in device packaging 14
Circuit Failure 14
Fluid leak 14
Moisture or humidity problem 13
No flow 12
Overfill 12
No display or display failure 12
Protective measure issue 11
No code available 10
Device displays error message 10
Corrosion 10
Kinked 10
Device emits odor 9
Device sensing issue 9
No Known Device Problem 9
Failure of device to self-test 9
No Information 9
Defective item 9
Material separation 9
Restricted flowrate 8
Bent 8
Loss of or failure to bond 7
Failure to sense 7
Detachment of device or device component 7
Device handling issue 6
Hole in material 6
Blockage within device or device component 5
Artifact 5
Split 5
Cut in material 4
Threader failure 4
Use of Device Issue 4
Pressure issue 4
Heat 4
Mechanical issue 4
Occlusion within device 4
Moisture damage 3
Fire 3
Burst 3
Alarm not visible 3
Defective Alarm 3
Component(s), broken 3
Component(s), overheating of 2
Connection error 2
Incorrect display 2
Filling problem 2
Filter 2
Delivered as unsterile product 2
Migration of device or device component 2
Output, low 2
No device output 2
Material deformation 2
Noise, Audible 2
Torn material 2
Device Contamination with biological material 2
Improper flow or infusion 2
Improper or incorrect procedure or method 2
Loss of power 2
Stretched 2
Smoking 2
Sterility 2
Failure to align 2
Malfunction 2
Incomplete or missing packaging 2
Failure to deliver 2
Device damaged prior to use 2
Temperature probe, loose 1
Valve(s), defective 1
Tube(s), defective 1
Burn hole(s) 1
Inaccurate delivery 1
Obstruction within device 1
Failure to advance 1
Sticking 1
Tears, rips, holes in device, device material 1
Sensor problems 1
Slippage of device or device component 1
Device inoperable 1
Total Device Problems 1810

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 1 0 0 0 0 0 0
Class II 2 1 0 1 1 1 0 3 3 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Fisher & Paykel Healthcare Inc II Dec-10-2008
2 Porous Media Corporation II Jun-20-2007
3 Respironics, Inc. II Jan-10-2007
4 Telefelx Medical II Mar-09-2010
5 Teleflex Medical II Dec-15-2015
6 Teleflex Medical II Apr-30-2015
7 Teleflex Medical II Feb-12-2015
8 Teleflex Medical II Jul-23-2014
9 Teleflex Medical II Jul-07-2014
10 Teleflex Medical II Jul-19-2012
11 Teleflex Medical II Jul-12-2011
12 Teleflex Medical I Aug-13-2010
13 Vapotherm, Inc. II Sep-25-2014

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