• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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
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 30
No code available 29
No Known Device Problem 23
Other (for use when an appropriate device code cannot be identified) 19
Crack 19
No Information 12
Solder joint failure 11
Device markings issue 7
Device operates differently than expected 7
Not audible alarm 7
Burn of device or device component 7
Device inoperable 6
Device Issue 6
Use of Device Issue 5
Electrical issue 4
Temperature issue 4
Corrosion 3
Incorrect display 2
Detachment of device component 2
Contamination during use 2
Bent 2
Hole in material 2
Kinked 2
Melted 2
Misconnection 2
Loss of power 2
Smoking 2
Device stops intermittently 2
Arcing 2
Dislodged or dislocated 2
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
Unknown (for use when the device problem is not known) 1
Failure to calibrate 1
Cut in material 1
Fumes or vapors 1
Device displays error message 1
Battery issue 1
Communication or transmission issue 1
Connection issue 1
Failure to deliver 1
Power source issue 1
Pressure 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
Slippage of device or device component 1
Occlusion within device 1
Overheating of device or device component 1
Device abrasion from instrument or another object 1
Loose or intermittent connection 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 265

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

-
-