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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)
Product CodeBTM
Regulation Number 868.5915
Device Class 2


Premarket Reviews
ManufacturerDecision
FLEXICARE MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
FOREMOUNT ENTERPRISE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SAFE BVM CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
XIAMEN COMPOWER MEDICAL TECH. CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 56 56
2018 53 53
2019 46 46
2020 26 26
2021 42 42
2022 34 34

Device Problems MDRs with this Device Problem Events in those MDRs
Break 22 22
Inflation Problem 16 16
Defective Component 14 14
Defective Device 14 14
Device Damaged Prior to Use 13 13
Component Missing 12 12
Device Operates Differently Than Expected 12 12
Appropriate Term/Code Not Available 12 12
Connection Problem 11 11
Device Issue 9 9
Device Operational Issue 9 9
Deflation Problem 9 9
Fitting Problem 8 8
Gas/Air Leak 7 7
Material Deformation 7 7
Device Dislodged or Dislocated 6 6
Detachment of Device or Device Component 6 6
Inadequacy of Device Shape and/or Size 6 6
Mechanical Problem 6 6
Missing Value Reason 6 6
Loose or Intermittent Connection 5 5
Disconnection 5 5
No Flow 5 5
Difficult to Open or Close 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Failure to Deliver 4 4
Leak/Splash 4 4
Collapse 4 4
Air Leak 4 4
Product Quality Problem 4 4
Therapeutic or Diagnostic Output Failure 4 4
Unintended Deflation 4 4
Insufficient Information 3 3
Physical Resistance/Sticking 3 3
Packaging Problem 3 3
Difficult to Remove 3 3
Material Separation 3 3
Material Puncture/Hole 3 3
Use of Device Problem 3 3
Detachment Of Device Component 3 3
Failure to Disconnect 3 3
Separation Failure 2 2
Structural Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Material Integrity Problem 2 2
Material Twisted/Bent 2 2
Crack 2 2
Disassembly 2 2
Device Alarm System 2 2
Hole In Material 2 2
Nonstandard Device 2 2
No Device Output 1 1
Increase in Pressure 1 1
Material Too Rigid or Stiff 1 1
Melted 1 1
Misconnection 1 1
Moisture Damage 1 1
Improper or Incorrect Procedure or Method 1 1
Suction Problem 1 1
Shipping Damage or Problem 1 1
Unexpected Therapeutic Results 1 1
Failure to Deliver Energy 1 1
Fire 1 1
Fluid/Blood Leak 1 1
Arcing at Paddles 1 1
Complete Blockage 1 1
Mechanical Jam 1 1
No Pressure 1 1
Optical Distortion 1 1
Improper Flow or Infusion 1 1
Incorrect Device Or Component Shipped 1 1
Device Markings/Labelling Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Expiration Date Error 1 1
Activation, Positioning or Separation Problem 1 1
Patient-Device Incompatibility 1 1
Obstruction of Flow 1 1
Incomplete or Missing Packaging 1 1
Invalid Sensing 1 1
Pressure Problem 1 1
Ventilation Problem in Device Environment 1 1
No Apparent Adverse Event 1 1
Patient Device Interaction Problem 1 1
Material Split, Cut or Torn 1 1
Incomplete or Inadequate Connection 1 1
Suction Failure 1 1
Premature Separation 1 1
Missing Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 96 96
No Consequences Or Impact To Patient 34 34
Missing Value Reason 31 31
No Clinical Signs, Symptoms or Conditions 31 31
Insufficient Information 22 22
Low Oxygen Saturation 15 15
No Patient Involvement 14 14
Cardiac Arrest 10 10
Death 9 9
No Code Available 9 9
Hypoxia 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Not Applicable 3 3
No Information 2 2
Cerebral Edema 2 2
Loss of consciousness 2 2
Respiratory Arrest 2 2
Low Blood Pressure/ Hypotension 2 2
Vomiting 2 2
Anemia 1 1
Hypoventilation 1 1
Decreased Respiratory Rate 1 1
Burn, Thermal 1 1
Fracture, Arm 1 1
Pneumothorax 1 1
Respiratory Distress 1 1
Seizures 1 1
Dyspnea 1 1
Endocarditis 1 1
Cardiopulmonary Arrest 1 1
Unspecified Tissue Injury 1 1
Asystole 1 1
Cardiovascular Insufficiency 1 1
Foreign Body In Patient 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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