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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 5
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 3
ENGINEERED MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
FISHER & PAYKEL HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 17
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 15
SUNRISE MEDICAL
  SUBSTANTIALLY EQUIVALENT 7
Ventlab Corporation
  SUBSTANTIALLY EQUIVALENT 1
VITAL SIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 4

Device Problems
Fire 35
No code available 30
No Known Device Problem 24
Other (for use when an appropriate device code cannot be identified) 19
Crack 19
No Information 13
Solder joint failure 11
Device markings issue 10
Burn of device or device component 8
Not audible alarm 7
Device operates differently than expected 7
Device inoperable 6
Use of Device Issue 6
Device Issue 6
Electrical issue 5
Temperature issue 4
Corrosion 3
Incorrect display 2
Detachment of device component 2
Contamination during use 2
Bent 2
Melted 2
Hole in material 2
Kinked 2
Loss of power 2
Smoking 2
Device stops intermittently 2
Pressure issue 2
Dislodged or dislocated 2
Failure to calibrate 2
Arcing 2
Misconnection 2
Occlusion within device 1
Overheating of device or device component 1
Failure to deliver 1
Unknown (for use when the device problem is not known) 1
Device displays error message 1
Battery issue 1
Communication or transmission issue 1
Connection issue 1
Cut in material 1
Fumes or vapors 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
Material integrity issue 1
Power source issue 1
Device handling issue 1
Telemetry discrepancy 1
Tube(s), splitting of 1
Twisting 1
Failure to power-up 1
Decrease in pressure 1
Material separation 1
Slippage of device or device component 1
Loose or intermittent connection 1
Mechanical issue 1
Device abrasion from instrument or another object 1
Fracture 1
Heat 1
Blockage within 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
Delayed alarm 1
Device alarm system issue 1
Failure to cycle 1
No display or display failure 1
Total Device Problems 283

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 4 2 1 0 1 0 1 2 0 1
Class III 0 0 0 0 0 0 0 1 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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