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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 210
Connection issue 168
Failure to power-up 167
Not audible alarm 136
Leak 126
Device operates differently than expected 100
Temperature issue 97
Insufficient heating 78
Device alarm system issue 71
Crack 55
Overheating of device or device component 50
Detachment of device component 40
Other (for use when an appropriate device code cannot be identified) 33
Device Issue 26
Break 24
Melted 24
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
Device sensing issue 13
Moisture or humidity problem 13
No flow 13
Overfill 12
No display or display failure 12
Protective measure issue 11
No code available 10
No Known Device Problem 10
Device displays error message 10
Corrosion 10
Kinked 10
Device emits odor 9
Failure of device to self-test 9
No Information 9
Defective item 9
Material separation 9
Pressure issue 8
Restricted flowrate 8
Bent 8
Loss of or failure to bond 7
Device handling issue 7
Detachment of device or device component 7
Failure to sense 7
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
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
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
Device Contamination with biological material 2
Improper flow or infusion 2
Noise, Audible 2
Torn material 2
Material deformation 2
Misassembled by Users 1
Infusion or flow issue 1
Foreign material present in device 1
Gas leak 1
Packaging issue 1
Electronic property issue 1
Sharp/jagged/rough/etched/scratched 1
Spark 1
Folded 1
Computer operating system issue 1
Temperature probe, loose 1
Valve(s), defective 1
Total Device Problems 1900

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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