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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
2020 1 1
2021 7 7
2022 7 7
2023 8 8
2024 6 6
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Material Integrity Problem 6 6
Physical Resistance/Sticking 5 5
Defective Device 4 4
Crack 3 3
Mechanical Problem 3 3
Improper or Incorrect Procedure or Method 2 2
Component Missing 2 2
Break 1 1
Disconnection 1 1
Inflation Problem 1 1
Leak/Splash 1 1
Decrease in Pressure 1 1
Material Rupture 1 1
Incomplete or Missing Packaging 1 1
Connection Problem 1 1
Device Dislodged or Dislocated 1 1
Gas/Air Leak 1 1
Output Problem 1 1
Pressure Problem 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 13 13
Insufficient Information 4 4
Respiratory Failure 3 3
Respiratory Insufficiency 2 2
Unspecified Respiratory Problem 2 2
Low Oxygen Saturation 2 2
Decreased Respiratory Rate 2 2
Bradycardia 2 2
Cardiac Arrest 2 2
Respiratory Arrest 1 1

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