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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 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 7
SUNRISE MEDICAL
  SUBSTANTIALLY EQUIVALENT 7
Ventlab Corporation
  SUBSTANTIALLY EQUIVALENT 1
VITAL SIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 4

Device Problems
Fire 36
No code available 30
No Known Device Problem 25
Other (for use when an appropriate device code cannot be identified) 19
Crack 19
No Information 14
Solder joint failure 11
Burn of device or device component 10
Device markings issue 10
Device Issue 7
Device inoperable 7
Device operates differently than expected 7
Not audible alarm 7
Use of Device Issue 6
Electrical issue 5
Temperature issue 4
Device stops intermittently 3
Corrosion 3
Contamination during use 3
Misconnection 2
Bent 2
Device displays error message 2
Smoking 2
Failure to calibrate 2
Dislodged or dislocated 2
Melted 2
Mechanical issue 2
Incorrect display 2
Kinked 2
Loss of power 2
Hole in material 2
Pressure issue 2
Arcing 2
Detachment of device component 2
Blockage within device or device component 1
Decrease in pressure 1
Device handling issue 1
Failure to power-up 1
Delayed alarm 1
Material separation 1
Fumes or vapors 1
Telemetry discrepancy 1
Device alarm system issue 1
Low battery 1
Loose or intermittent connection 1
Cut in material 1
Slippage of device or device component 1
Inadequate user interface 1
Electrical overstress 1
Overheating of device or device component 1
Break 1
Heat 1
Unknown (for use when the device problem is not known) 1
Maintenance does not comply to manufacturers recommendations 1
Failure to deliver 1
Failure to charge 1
Loss of or failure to bond 1
No display or display failure 1
Tube(s), splitting of 1
Device abrasion from instrument or another object 1
Connection issue 1
Occlusion within device 1
Twisting 1
Circuit Failure 1
Failure to cycle 1
Fracture 1
Communication or transmission issue 1
Human-Device Interface Issue 1
Device Cleaning Issue 1
Material integrity issue 1
Power source issue 1
Flare or flash 1
Battery issue 1
Total Device Problems 295

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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