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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

MDR Year MDR Reports MDR Events
2016 7 7
2017 5 5
2018 3 3
2019 6 6
2020 1 1
2021 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 2 2
Sticking 2 2
Device Inoperable 2 2
Physical Resistance/Sticking 2 2
Break 2 2
Inflation Problem 2 2
Detachment of Device or Device Component 2 2
Device Operates Differently Than Expected 2 2
Material Perforation 2 2
Defective Device 1 1
Torn Material 1 1
Patient Device Interaction Problem 1 1
Material Puncture/Hole 1 1
Difficult to Remove 1 1
Hole In Material 1 1
Improper or Incorrect Procedure or Method 1 1
Device Damaged Prior to Use 1 1
Tear, Rip or Hole in Device Packaging 1 1
Material Integrity Problem 1 1
Detachment Of Device Component 1 1
Decoupling 1 1
Disconnection 1 1
Kinked 1 1
Loose or Intermittent Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 12 12
No Consequences Or Impact To Patient 3 3
No Clinical Signs, Symptoms or Conditions 2 2
Missing Value Reason 2 2
Bruise/Contusion 1 1
Not Applicable 1 1
No Code Available 1 1
Insufficient Information 1 1
Sudden Cardiac Death 1 1
Airway Obstruction 1 1
Cardiopulmonary Arrest 1 1

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