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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device heater, breathing system w/wo controller (not humidifier or nebulizer
Regulation Description Breathing system heater.
Product CodeBZE
Regulation Number 868.5270
Device Class 2


Premarket Reviews
ManufacturerDecision
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
BIRD PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 2
FISHER & PAYKEL HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 3
MARQUEST MEDICAL PRODUCTS INC
  SUBSTANTIALLY EQUIVALENT 1
RESPIRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Crack 43
Insufficient heating 32
Temperature issue 22
Leak 15
Device Issue 14
Device operates differently than expected 14
Power source issue 8
Air leak 6
Connection issue 4
Cut in material 4
Failure to power-up 3
Other (for use when an appropriate device code cannot be identified) 3
Detachment of device component 3
Hole in material 3
No Information 3
No Known Device Problem 3
Overheating of device or device component 2
Melted 2
Circuit Failure 2
Bent 2
Not audible alarm 2
Detachment of device or device component 2
Material separation 2
Smoking 1
Use of Device Issue 1
Fitting problem 1
Failure to advance 1
Spark 1
Device damaged prior to use 1
Failure to deliver 1
Material integrity issue 1
Mechanics altered 1
Moisture or humidity problem 1
Changes in ambient temperature in device environment 1
Artifact 1
Defective Alarm 1
Break 1
Burn of device or device component 1
Device emits odor 1
Material discolored 1
Disconnection 1
Shock, electrical 1
Fluid leak 1
Heat, failure to 1
Torn material 1
Ventilation issue in device environment 1
No code available 1
Device handling issue 1
Total Device Problems 219

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

Recalls
Manufacturer Recall Class Date Posted
1 Carefusion 2200 Inc II Sep-23-2014
2 Carefusion 2200 Inc I Jun-29-2012

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