• 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 Show TPLC since 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

Device Problems
Device Issue 29
Hole In Material 20
Crack 15
Split 13
Device Operates Differently Than Expected 11
Material Split, Cut or Torn 11
Leak / Splash 10
Disconnection 9
Break 8
Fitting Problem 6
Mechanical Problem 5
Connection Problem 5
Device Handling Problem 4
Gas Leak 4
Inadequacy of Device Shape and/or Size 3
Physical Property Issue 3
Detachment Of Device Component 3
Failure of Device to Self-Test 2
Torn Material 2
Insufficient Information 2
Material Integrity Problem 2
Use of Device Problem 2
Infusion or Flow Problem 2
Overheating of Device 2
Loose or Intermittent Connection 2
Circuit Failure 1
Temperature Problem 1
Seal 1
Stretched 1
Device Damaged Prior to Use 1
Adverse Event Without Identified Device or Use Problem 1
Collapse 1
Breathing Circuit 1
Material Too Rigid or Stiff 1
Device Contamination with Chemical or Other Material 1
Partial Blockage 1
Connector 1
Material Separation 1
No Pressure 1
Total Device Problems 189

Recalls
Manufacturer Recall Class Date Posted
1 Hamilton Medical, Inc. II Jul-02-2015

-
-