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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device ventilator, non-continuous (respirator)
Regulation Description Noncontinuous ventilator (IPPB).
Product CodeBZD
Regulation Number 868.5905
Device Class 2


Premarket Reviews
ManufacturerDecision
AIRSEP CORP.
  SUBSTANTIALLY EQUIVALENT 1
BIRD PRODUCTS
  SUBSTANTIALLY EQUIVALENT 3
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 3
ENGINEERED MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
FISHER & PAYKEL HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 19
GALEMED CORP.
  SUBSTANTIALLY EQUIVALENT 1
HAMILTON
  SUBSTANTIALLY EQUIVALENT 1
INNOMED, INC.
  SUBSTANTIALLY EQUIVALENT 2
INVACARE CORP.
  SUBSTANTIALLY EQUIVALENT 5
KENDALL
  SUBSTANTIALLY EQUIVALENT 1
MALLINCKRODT
  SUBSTANTIALLY EQUIVALENT 6
MEDICAL INDUSTRIES AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDICOMP
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERITS
  SUBSTANTIALLY EQUIVALENT 1
NELLCOR PURITAN BENNETT
  SUBSTANTIALLY EQUIVALENT 11
NOVAMETRIX
  SUBSTANTIALLY EQUIVALENT 1
RESMED
  SUBSTANTIALLY EQUIVALENT 79
RESPIRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 70
SALTER LABS
  SUBSTANTIALLY EQUIVALENT 3
SENSORMEDICS
  SUBSTANTIALLY EQUIVALENT 7
SUNRISE MEDICAL
  SUBSTANTIALLY EQUIVALENT 7
Ventlab Corporation
  SUBSTANTIALLY EQUIVALENT 1
VITAL SIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 4

Device Problems
Fire 40
No Known Device Problem 32
No code available 30
Device operates differently than expected 26
Device Issue 26
Other (for use when an appropriate device code cannot be identified) 19
Crack 19
Burn of device or device component 14
No Information 14
Solder joint failure 11
Device markings issue 10
Not audible alarm 10
No display or display failure 7
Device inoperable 7
Use of Device Issue 7
Electrical issue 6
Device stops intermittently 5
Device displays error message 5
Temperature issue 4
Contamination during use 3
Corrosion 3
Incorrect display 2
Bent 2
Blockage within device or device component 2
Detachment of device component 2
Misconnection 2
Loss of power 2
Hole in material 2
Kinked 2
Loose or intermittent connection 2
Mechanical issue 2
Melted 2
Material integrity issue 2
Smoking 2
Power source issue 2
Pressure issue 2
Connection issue 2
Dislodged or dislocated 2
Failure to deliver 2
Inaccurate delivery 2
Arcing 2
Failure to calibrate 2
Cut in material 2
Fumes or vapors 1
Low battery 1
Telemetry discrepancy 1
Tube(s), splitting of 1
Twisting 1
Fitting problem 1
Unknown (for use when the device problem is not known) 1
Electrical overstress 1
Flare or flash 1
Human-Device Interface Issue 1
Inadequate user interface 1
Maintenance does not comply to manufacturers recommendations 1
Detachment of device or device component 1
Battery issue 1
Communication or transmission issue 1
Unintended movement 1
Device abrasion from instrument or another object 1
Inaccurate flowrate 1
Fracture 1
Heat 1
Failure to power-up 1
Decrease in pressure 1
Material separation 1
Slippage of device or device component 1
Occlusion within device 1
Overheating of device or device component 1
Loss of or failure to bond 1
Break 1
Failure to charge 1
Circuit Failure 1
Device Cleaning Issue 1
Failure to cycle 1
Delayed alarm 1
Device alarm system issue 1
Device handling issue 1
Total Device Problems 377

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 4 2 1 0 1 0 1 2 0 1 0
Class III 0 0 0 0 0 0 0 1 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Beevers Manufacturing & Supply, Inc. II Dec-02-2014
2 Beevers Manufacturing & Supply, Inc. II Dec-01-2014
3 Cardinal Health II May-14-2008
4 Cardinal Health II Jul-12-2007
5 DeVilbiss Healthcare LLC III Jul-01-2014
6 Fisher & Paykel Healthcare Inc II Jun-27-2007
7 Fisher & Paykel Healthcare, Ltd. II May-30-2013
8 Resmed Corporation II Aug-16-2016
9 Resmed Corporation II Jul-03-2007
10 Respironics II Jun-17-2009
11 Respironics, Inc. II Apr-24-2008
12 Sunrise Medical HHG Inc. dba DeVilbiss Healthcare II Aug-10-2011
13 Teleflex Medical II Jun-07-2007

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