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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 1

Device Problems
Not audible alarm 74
Failure to cycle 49
Device inoperable 49
Decrease in pressure 32
Inaccurate delivery 22
Device alarm system issue 21
Other (for use when an appropriate device code cannot be identified) 9
Device operates differently than expected 8
No code available 7
Increase in pressure 7
Out-of-box failure 6
Noise, Audible 5
Calibration issue 5
Pressure issue 5
Defective Alarm 5
Shock, electrical 4
Failure to calibrate 4
Device displays error message 4
Connection error 4
Smoking 3
Low readings 3
Output, high 3
Overheating of device or device component 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
Loose or intermittent connection 2
Melted 2
Moisture damage 2
Disconnection 2
Erratic display 2
Incorrect display 2
Moisture or humidity problem 2
No Known Device Problem 1
Temperature issue 1
Misassembled by Users 1
Spark 1
Blocked connection 1
Electromagnetic compatibility issue 1
Human-Device Interface Issue 1
Improper flow or infusion 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
Alarm, failure of high inspiratory pressure 1
Overfill 1
Unknown (for use when the device problem is not known) 1
Defective component 1
Improper or incorrect procedure or method 1
Noise 1
Electro-magnetic interference (EMI) 1
Explode 1
Filter 1
Improper gas output 1
Head immobilizer failure 1
Leak 1
Device maintenance issue 1
Loss of power 1
Failure to power-up 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 400

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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