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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device humidifier, non-direct patient interface (home-use)
Regulation Description Therapeutic humidifier for home use.
Product CodeKFZ
Regulation Number 868.5460
Device Class 1

Device Problems
Humidifier 36
Adverse Event Without Identified Device or Use Problem 23
Use of Device Problem 11
Improper or Incorrect Procedure or Method 10
Fire 7
Smoking 3
Insufficient Information 2
Melted 2
Thermal Decomposition of Device 2
Device Damaged Prior to Use 1
Human-Device Interface Problem 1
Sparking 1
No Apparent Adverse Event 1
Thermometer 1
Device Handling Problem 1
Total Device Problems 102

Recalls
Manufacturer Recall Class Date Posted
1 Bigwall Enterprises II Feb-25-2016

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