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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device mixer, breathing gases, anesthesia inhalation
Regulation Description Breathing gas mixer.
Product CodeBZR
Regulation Number 868.5330
Device Class 2


Premarket Reviews
ManufacturerDecision
ATOM MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
BIRD PRODUCTS
  SUBSTANTIALLY EQUIVALENT 5
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 1
DRAEGER MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
HAMILTON
  SUBSTANTIALLY EQUIVALENT 2
MAXTEC
  SUBSTANTIALLY EQUIVALENT 1
MCKESSON
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEWPORT
  SUBSTANTIALLY EQUIVALENT 1
OHMEDA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
PRAXAIR
  SUBSTANTIALLY EQUIVALENT 1
PRECISION MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
SECHRIST INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
SHILEY, INC
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS
  SUBSTANTIALLY EQUIVALENT 2
VITAL SIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Not audible alarm 36
Inaccurate delivery 33
Out-of-box failure 23
Device alarm system issue 13
Device operates differently than expected 5
Failure to calibrate 3
False alarm 3
Detachment of device component 2
Inaccurate flowrate 2
Improper gas output 2
Leak 2
Alarm system, failure of gas-leak/loss 1
Other (for use when an appropriate device code cannot be identified) 1
Excess flow or overinfusion 1
Connection error 1
Defective Alarm 1
Delayed alarm 1
Device sensing issue 1
Total Device Problems 131

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


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