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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device vaporizer, anesthesia, non-heated
Regulation Description Anesthetic vaporizer.
Product CodeCAD
Regulation Number 868.5880
Device Class 2


Premarket Reviews
ManufacturerDecision
BEAR MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
DATEX-OHMEDA, INC.
  SUBSTANTIALLY EQUIVALENT 5
DRAEGER MEDICAL
  SUBSTANTIALLY EQUIVALENT 7
OHMEDA MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS
  SUBSTANTIALLY EQUIVALENT 2
SOUTHMEDIC, INC.
  SUBSTANTIALLY EQUIVALENT 5

Device Problems
Device inoperable 11
Device operates differently than expected 5
No code available 4
Component missing 3
Leak 3
Break 3
Mechanical issue 3
Loose or intermittent connection 1
Insufficient flow or underinfusion 1
Low test results 1
Computer operating system issue 1
Mechanical jam 1
No flow 1
Self-activation or keying 1
Connection issue 1
Infusion or flow issue 1
Total Device Problems 41

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 1 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Penlon, Ltd. II Jul-02-2013

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