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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device ventilator, continuous, non-life-supporting
Regulation Description Continuous ventilator.
Product CodeMNS
Regulation Number 868.5895
Device Class 2


Premarket Reviews
ManufacturerDecision
INNOMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
NELLCOR PURITAN BENNETT
  SUBSTANTIALLY EQUIVALENT 1
RESMED
  SUBSTANTIALLY EQUIVALENT 14
RESPIRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 16
SUNRISE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device displays error message 9
No flow 5
Device alarm system issue 4
Not audible alarm 3
Failure to power-up 3
Increase in pressure 2
Loss of power 2
Device operates differently than expected 1
Failure to pump 1
Sticking 1
Device stops intermittently 1
Unexpected therapeutic results 1
Device inoperable 1
Improper or incorrect procedure or method 1
Alarm, failure of warning 1
Mechanical issue 1
No device output 1
Overheating of device or device component 1
Pressure issue 1
No Information 1
Noise, Audible 1
Total Device Problems 42

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

Recalls
Manufacturer Recall Class Date Posted
1 Respironics California Inc I Jul-07-2009
2 Respironics, Inc. II Apr-24-2008

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