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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device ventilator, emergency, manual (resuscitator)
Regulation Description Manual emergency ventilator.
Product CodeBTM
Regulation Number 868.5915
Device Class 2


Premarket Reviews
ManufacturerDecision
AMBU A/S
  SUBSTANTIALLY EQUIVALENT 1
FLEXICARE MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
FOREMOUNT ENTERPRISE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
XIAMEN COMPOWER MEDICAL TECH. CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 92 92
2017 56 56
2018 53 53
2019 46 46
2020 26 26
2021 30 30

Device Problems MDRs with this Device Problem Events in those MDRs
Device Issue 31 31
Break 30 30
Separation Failure 21 21
Device Operates Differently Than Expected 21 21
Device Operational Issue 19 19
Inflation Problem 19 19
Difficult to Remove 16 16
Device Damaged Prior to Use 16 16
Connection Problem 14 14
Appropriate Term/Code Not Available 14 14
Defective Device 13 13
Defective Component 12 12
Component Missing 10 10
Deflation Problem 9 9
Missing Value Reason 8 8
Fitting Problem 8 8
Inadequacy of Device Shape and/or Size 6 6
Detachment Of Device Component 6 6
Disconnection 6 6
Material Deformation 6 6
Activation, Positioning or SeparationProblem 6 6
Air Leak 6 6
Crack 5 5
Material Separation 5 5
Detachment of Device or Device Component 5 5
Device Dislodged or Dislocated 5 5
Gas Leak 5 5
No Flow 5 5
Material Integrity Problem 5 5
Loose or Intermittent Connection 5 5
Sticking 5 5
Product Quality Problem 4 4
Failure to Disconnect 4 4
Kinked 4 4
Leak/Splash 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Mechanical Problem 4 4
Collapse 3 3
Packaging Problem 3 3
Therapeutic or Diagnostic Output Failure 3 3
Torn Material 3 3
Insufficient Information 3 3
Unintended Deflation 3 3
Material Twisted/Bent 2 2
Bent 2 2
Disassembly 2 2
Melted 2 2
Nonstandard Device 2 2
Hole In Material 2 2
Use of Device Problem 2 2
Incomplete or Missing Packaging 2 2
Failure to Deliver 2 2
Difficult to Open or Close 2 2
Difficult to Open or Remove Packaging Material 2 2
Physical Resistance/Sticking 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Device Markings/Labelling Problem 2 2
Device Alarm System 2 2
Failure To Adhere Or Bond 1 1
Restricted Flow rate 1 1
Misconnection 1 1
Moisture Damage 1 1
Device Displays Incorrect Message 1 1
Invalid Sensing 1 1
Improper or Incorrect Procedure or Method 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Incorrect Device Or Component Shipped 1 1
No Pressure 1 1
Optical Distortion 1 1
Pressure Problem 1 1
Ventilation Problem in Device Environment 1 1
Incomplete or Inadequate Connection 1 1
Suction Failure 1 1
Patient-Device Incompatibility 1 1
Suction Problem 1 1
Shipping Damage or Problem 1 1
Obstruction of Flow 1 1
Structural Problem 1 1
Expiration Date Error 1 1
Material Too Rigid or Stiff 1 1
Material Puncture/Hole 1 1
Fire 1 1
Arcing at Paddles 1 1
Complete Blockage 1 1
Mechanical Jam 1 1
Patient Device Interaction Problem 1 1
Material Split, Cut or Torn 1 1
No Apparent Adverse Event 1 1
Improper Flow or Infusion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 147 147
Missing Value Reason 54 54
No Consequences Or Impact To Patient 40 40
Not Applicable 25 25
No Patient Involvement 18 18
No Information 14 14
Death 12 12
No Clinical Signs, Symptoms or Conditions 11 11
Insufficient Information 10 10
No Code Available 10 10
Low Oxygen Saturation 8 8
Cardiac Arrest 8 8
Hypoxia 5 5
Low Blood Pressure/ Hypotension 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Respiratory Arrest 2 2
Anemia 1 1
Foreign Body In Patient 1 1
Asystole 1 1
Cardiovascular Insufficiency 1 1
Hypoventilation 1 1
Respiratory Distress 1 1
Seizures 1 1
Cardiopulmonary Arrest 1 1
Dyspnea 1 1
Endocarditis 1 1
Burn, Thermal 1 1
Brain Injury 1 1
Fracture, Arm 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Sun Med, LLC II Jun-09-2018
2 Vyaire Medical I Aug-08-2018
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