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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device resuscitator, manual, non self-inflating
Regulation Description Noncontinuous ventilator (IPPB).
Definition A non self-inflating manual resuscitator, also called a hyperinflation system, is a manual ventilator intended to ventilate a patient by forcing a volume of fresh gas into the patient via compression of the ventilator bag; a source of compressed breathing gas is required to inflate the bag.
Product CodeNHK
Regulation Number 868.5905
Device Class 2

Device Problems
Device Damaged Prior to Use 17
Defective Component 5
Device Operates Differently Than Expected 5
Infusion or Flow Problem 3
Material Perforation 2
Fracture 2
Bag 2
Tear, Rip or Hole in Device Packaging 1
Material Puncture/Hole 1
Break 1
Decoupling 1
Patient Device Interaction Problem 1
Loose or Intermittent Connection 1
Valve, PEEP (Positive End Expiratory Pressure) 1
Total Device Problems 43