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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device ventilator, high frequency
Product CodeLSZ
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
1 0 0 1 0 1 3 2 4 2

Device Problems
Not audible alarm 76
Device inoperable 51
Failure to cycle 49
Decrease in pressure 33
Inaccurate delivery 22
Device alarm system issue 21
Device operates differently than expected 9
Other (for use when an appropriate device code cannot be identified) 9
Increase in pressure 8
No code available 7
Out-of-box failure 6
Pressure issue 5
Device displays error message 5
Calibration issue 5
Defective Alarm 5
Noise, Audible 5
Shock, electrical 4
Failure to calibrate 4
Connection error 4
Overheating of device or device component 3
Smoking 3
Low readings 3
Output, high 3
Alarm, intermittent 3
False alarm 3
Alarm not visible 3
Calibration error 2
Detachment of device component 2
Alarm, audible 2
Output, low 2
Melted 2
Moisture damage 2
Incorrect display 2
Loose or intermittent connection 2
Disconnection 2
Erratic display 2
Overfill 2
Moisture or humidity problem 2
No Known Device Problem 2
Temperature issue 1
Misassembled by Users 1
Electromagnetic compatibility issue 1
Human-Device Interface Issue 1
Improper flow or infusion 1
Maintenance does not comply to manufacturers recommendations 1
Spark 1
Blocked connection 1
Alarm, failure of high inspiratory pressure 1
Device stops intermittently 1
Alarm system, failure of gas-leak/loss 1
Tears, rips, holes in device, device material 1
Unexpected therapeutic results 1
User used incorrect product for intended use 1
Difficult to Program or Calibrate 1
Loss of power 1
Failure to power-up 1
Improper or incorrect procedure or method 1
Noise 1
Unknown (for use when the device problem is not known) 1
Defective component 1
No display or display failure 1
Electrical issue 1
Explode 1
Filter 1
Improper gas output 1
Head immobilizer failure 1
Leak 1
Device maintenance issue 1
Electro-magnetic interference (EMI) 1
Delayed alarm 1
Failure to run on AC/DC 1
Air leak 1
Component(s), overheating of 1
Circuit Failure 1
Component(s), broken 1
Alarm, failure of warning 1
Break 1
Total Device Problems 413

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

Recalls
Manufacturer Recall Class Date Posted
1 Bunnell, Inc. I Dec-14-2012
2 Bunnell, Inc. II Jan-14-2011

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