• 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 set, tubing and support, ventilator (w harness)
Regulation Description Ventilator tubing.
Product CodeBZO
Regulation Number 868.5975
Device Class 1


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
BIOVNA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
HAMILTON
  SUBSTANTIALLY EQUIVALENT 1
HUDSON RESPIRATORY CARE
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 1
NELLCOR PURITAN BENNETT
  SUBSTANTIALLY EQUIVALENT 1
RESPIRATORY SUPPORT PRODUCTS, INC. (RSP)
  SUBSTANTIALLY EQUIVALENT 2
SECHRIST INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS
  SUBSTANTIALLY EQUIVALENT 1
THORATEC CORP.
  SUBSTANTIALLY EQUIVALENT 1
Ventlab Corporation
  SUBSTANTIALLY EQUIVALENT 2
VITAL SIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Leak 103
Crack 36
Hole in material 27
Device Issue 15
Melted 14
Device operates differently than expected 12
Other (for use when an appropriate device code cannot be identified) 11
Fitting problem 8
Cut in material 7
Tears, rips, holes in device, device material 6
Loose or intermittent connection 5
Connection issue 5
Split 4
Detachment of device component 4
Disconnection 3
Burn of device or device component 3
Circuit Failure 3
Overheating of device or device component 3
Material rigid or stiff 3
Tube(s), splitting of 2
Use of Device Issue 2
Electrical wires, defective 2
Failure of device to self-test 2
Foreign material present in device 2
Material integrity issue 2
Material torqued 1
Torn material 1
Malfunction 1
Component(s), broken 1
Heat 1
Total Device Problems 289

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

Recalls
Manufacturer Recall Class Date Posted
1 Draeger Medical, Inc. II Apr-10-2014
2 Fisher & Paykel Healthcare, Ltd. I May-20-2014
3 Fisher & Paykel Healthcare, Ltd. I Jan-03-2013
4 Hamilton Medical, Inc. II Jul-02-2015

-
-