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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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 21
Crack 14
Split 13
Device Operates Differently Than Expected 12
Leak / Splash 11
Disconnection 10
Break 8
Fitting Problem 8
Connection Problem 7
Material Split, Cut or Torn 6
Detachment Of Device Component 5
Mechanical Problem 4
Gas Leak 4
Material Integrity Problem 4
Use of Device Problem 3
Physical Property Issue 3
Inadequacy of Device Shape and/or Size 3
Material Too Rigid or Stiff 3
Device Handling Problem 3
Failure of Device to Self-Test 2
Device Contamination with Chemical or Other Material 2
Overheating of Device 2
Torn Material 2
Insufficient Information 2
Loose or Intermittent Connection 2
Infusion or Flow Problem 2
Seal 1
Obstruction of Flow 1
Adverse Event Without Identified Device or Use Problem 1
Circuit Failure 1
Device Damaged Prior to Use 1
Connector 1
Thermal Decomposition of Device 1
Computer Software Problem 1
Stretched 1
Collapse 1
Temperature Problem 1
Partial Blockage 1
Breathing Circuit 1
Material Separation 1
Material Torqued 1
Total Device Problems 200

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

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