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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device ventilator, continuous, minimal ventilatory support,facility use
Regulation Description Continuous ventilator.
Product CodeMNT
Regulation Number 868.5895
Device Class 2


Premarket Reviews
ManufacturerDecision
FISHER & PAYKEL HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 1
MALLINCKRODT
  1
NELLCOR PURITAN BENNETT
  SUBSTANTIALLY EQUIVALENT 1
RESMED
  SUBSTANTIALLY EQUIVALENT 1
RESPIRONICS, INC.
  2
  SUBSTANTIALLY EQUIVALENT 5

Device Problems
Device displays error message 190
Device operates differently than expected 161
Device inoperable 95
Failure to power-up 53
Loss of power 36
Device alarm system issue 27
Battery issue 25
No display or display failure 22
Pressure issue 18
Failure to charge 12
No flow 11
Temperature issue 11
Power source issue 11
No Known Device Problem 10
Failure to sense 10
Leak 10
Failure of device to self-test 9
Device emits odor 5
Failure to run on AC/DC 5
Break 5
Data Issue 5
No code available 4
Device sensing issue 4
Not audible alarm 4
Overheating of device or device component 4
Electrical issue 4
Device stops intermittently 4
Device Issue 4
Calibration issue 3
Charging issue 3
Material discolored 3
Occlusion within device 3
Calibration error 3
Air leak 3
Device handling issue 3
Delivery system failure 2
Incorrect display 2
Shock, electrical 2
Premature discharge of battery 2
Application interface becomes non-functional or program exits abnormally 2
Improper gas output 2
Decrease in pressure 2
Increase in pressure 2
Infusion or flow issue 2
Mechanics altered 2
Smoking 2
Valve(s), failure of 2
Volume accuracy issue 2
Improper or incorrect procedure or method 1
Fitting problem 1
Component missing 1
Out-of-box failure 1
Tidal volume fluctuations 1
Undersensing 1
Alarm, failure of high inspiratory pressure 1
Failure to calibrate 1
Device or device fragments location unknown 1
Use of Device Issue 1
Spark 1
Medical Gas Supply problem 1
Moisture or humidity problem 1
No Pressure 1
Output below specifications 1
Output issue 1
Communication or transmission issue 1
Connection issue 1
Improper alarm 1
Improper device output 1
Improper flow or infusion 1
Failure to pump 1
Unintended collision 1
No device output 1
Excess flow or overinfusion 1
Mechanical issue 1
Melted 1
Poor quality image 1
Circuit Failure 1
Use of Incorrect Control Settings 1
Insufficient cooling 1
Defective Alarm 1
Low audible alarm 1
Failure to Adhere or Bond 1
Ventilation issue in device environment 1
Reset issue 1
Noise, Audible 1
Total Device Problems 843

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

Recalls
Manufacturer Recall Class Date Posted
1 Puritan Bennett Corporation II Jan-09-2007
2 Respironics California Inc I May-18-2017
3 Respironics California Inc II Mar-27-2017
4 Respironics California Inc I Jun-17-2013
5 Respironics California Inc I Aug-31-2012
6 Respironics California Inc II Nov-24-2010
7 Respironics California Inc II Nov-11-2009
8 Respironics, Inc. II Apr-24-2008

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