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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
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


Premarket Reviews
ManufacturerDecision
A PLUS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 15 15
2015 32 32
2016 7 7
2017 5 5
2018 3 3
2019 6 6
2020 1 1
2021 7 7
2022 7 7
2023 8 8
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Device Damaged Prior to Use 19 19
Loose or Intermittent Connection 12 12
Break 7 7
Device Operates Differently Than Expected 7 7
Physical Resistance/Sticking 5 5
Material Integrity Problem 5 5
Defective Component 5 5
Defective Device 5 5
Infusion or Flow Problem 3 3
Crack 3 3
Inflation Problem 3 3
Material Rupture 3 3
Sticking 2 2
Device Inoperable 2 2
Improper or Incorrect Procedure or Method 2 2
Material Perforation 2 2
Mechanical Problem 2 2
Decrease in Pressure 2 2
Fracture 2 2
Detachment Of Device Component 2 2
Detachment of Device or Device Component 2 2
Air Leak 2 2
Leak/Splash 2 2
Component Missing 2 2
Incomplete or Missing Packaging 1 1
Tear, Rip or Hole in Device Packaging 1 1
Split 1 1
Device Dislodged or Dislocated 1 1
Pressure Problem 1 1
Torn Material 1 1
No Apparent Adverse Event 1 1
Patient Device Interaction Problem 1 1
Decoupling 1 1
Disconnection 1 1
Hole In Material 1 1
Kinked 1 1
Material Puncture/Hole 1 1
Product Quality Problem 1 1
Difficult to Remove 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 30 30
No Known Impact Or Consequence To Patient 20 20
No Consequences Or Impact To Patient 16 16
No Clinical Signs, Symptoms or Conditions 11 11
No Information 5 5
Insufficient Information 4 4
Missing Value Reason 2 2
Unspecified Respiratory Problem 2 2
Decreased Respiratory Rate 2 2
Bradycardia 2 2
Bruise/Contusion 1 1
Cardiac Arrest 1 1
Cardiopulmonary Arrest 1 1
Death 1 1
Sudden Cardiac Death 1 1
Low Oxygen Saturation 1 1
Respiratory Failure 1 1
Airway Obstruction 1 1
Respiratory Insufficiency 1 1
No Code Available 1 1
Not Applicable 1 1

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