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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device mask, oxygen
Regulation Description Oxygen mask.
Product CodeBYG
Regulation Number 868.5580
Device Class 1


Premarket Reviews
ManufacturerDecision
B & F MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 3
KENDALL
  SUBSTANTIALLY EQUIVALENT 1
LIFE SUPPORT PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL INDUSTRIES AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
NELLCOR PURITAN BENNETT
  SUBSTANTIALLY EQUIVALENT 1
SALTER LABS
  SUBSTANTIALLY EQUIVALENT 2
VITAL SIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 1
WESTMED, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Detachment of device or device component 43
Connection issue 12
Occlusion within device 6
Disconnection 5
Detachment of device component 4
Decoupling 4
Inflation issue 4
Kinked 4
Material integrity issue 4
No flow 4
Incorrect device or component shipped 3
Normal 2
Fitting problem 2
Device Issue 2
Leak 2
Hole in material 2
Component falling 2
Air leak 2
Foreign material present in device 2
Blockage within device or device component 1
Loss of or failure to bond 1
Break 1
Crack 1
Restricted flowrate 1
Material puncture 1
Material rupture 1
Loose 1
Migration of device or device component 1
Misconnection 1
Obstruction within device 1
Split 1
Failure to disconnect 1
Malposition of device 1
Other (for use when an appropriate device code cannot be identified) 1
Defective component 1
Infusion or flow issue 1
Device markings issue 1
Device operates differently than expected 1
Packaging issue 1
Torn material 1
Noise, Audible 1
Total Device Problems 131

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 5 0 0 1 0 0 1
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 ConvaTec, Inc II May-24-2017
2 Convatec Inc. II Feb-15-2011
3 King Systems Corp. II Apr-06-2011
4 Salter Laboratories, Division of Regulatory Affairs II Oct-26-2011
5 Salter Labs II Jul-23-2014
6 Smiths Medical II Jun-24-2011
7 Vital Signs Devices, a GE Healthcare Company II Jun-29-2011

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