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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device circuit, breathing (w connector, adaptor, y piece)
Regulation Description Anesthesia breathing circuit.
Product CodeCAI
Regulation Number 868.5240
Device Class 1


Premarket Reviews
ManufacturerDecision
AMBU INTERNATIONAL A/S
  SUBSTANTIALLY EQUIVALENT 1
ARC MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 3
BEAR MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOVNA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
BIRD PRODUCTS
  SUBSTANTIALLY EQUIVALENT 4
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 1
DRAEGER MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 1
KING SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
MARQUEST MEDICAL PRODUCTS INC
  SUBSTANTIALLY EQUIVALENT 4
MEDICAL
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1
MEDICOMP
  SUBSTANTIALLY EQUIVALENT 2
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 9
MONAGHAN MEDICAL CORP
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIC SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PORTEX, INC.
  SUBSTANTIALLY EQUIVALENT 1
SECHRIST INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
THORATEC CORP.
  SUBSTANTIALLY EQUIVALENT 1
Ventlab Corporation
  SUBSTANTIALLY EQUIVALENT 1
VITAL SIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 5

Device Problems
Leak 148
Crack 84
Split 34
Disconnection 31
Loose or intermittent connection 25
Gas leak 23
Air leak 18
Device Issue 14
Device alarm system issue 10
Detachment of device component 10
Hole in material 9
Degraded 8
Melted 7
Break 6
Tears, rips, holes in device, device material 5
Tube(s), splitting of 5
No Known Device Problem 5
Malfunction 4
Use of Device Issue 4
Material separation 3
Component(s), broken 3
Cut in material 3
Connection issue 3
Device operates differently than expected 3
No flow 3
Material rupture 2
Device inoperable 2
Unstable 2
Tear, rip or hole in device packaging 2
Loss of or failure to bond 2
Connection error 2
Other (for use when an appropriate device code cannot be identified) 2
Unknown (for use when the device problem is not known) 1
Defective component 1
Burn hole(s) 1
Out-of-box failure 1
Residue after decontamination 1
Failure to deliver 1
Underdelivery 1
Fracture 1
Smoking 1
Sticking 1
Tidal volume fluctuations 1
Disassembly 1
Component(s), overheating of 1
Method, improper/incorrect 1
Misassembled 1
Normal 1
Occlusion within device 1
Replace 1
Obstruction within device 1
Communication or transmission issue 1
No Pressure 1
Protective measure issue 1
Torn material 1
Ventilation issue in device environment 1
Misassembled by Users 1
Infusion or flow issue 1
Total Device Problems 508

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 1 1 0 0 0
Class II 0 0 2 0 0 1 1 1 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 GE Medical Systems, LLC II Sep-09-2009
2 Impact Instrumentation, Inc. II Jan-12-2012
3 Instrumentation Industries Inc II Dec-29-2013
4 King Systems Corp. I Sep-27-2013
5 King Systems Corp. II Feb-03-2009
6 Teleflex Medical I Sep-30-2014
7 Teleflex Medical II Jul-23-2014

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