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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
ARCHEON
  SUBSTANTIALLY EQUIVALENT 1
SAFE BVM CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
  1.  K212905  Sotair Device
XIAMEN COMPOWER MEDICAL TECH. CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 46 46
2020 26 26
2021 42 42
2022 35 35
2023 48 48
2024 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Inflation Problem 19 19
Break 17 17
Defective Device 13 13
Defective Component 11 11
Deflation Problem 10 10
Detachment of Device or Device Component 10 10
Gas/Air Leak 10 10
Pressure Problem 9 9
Device Damaged Prior to Use 9 9
Component Missing 7 7
Connection Problem 7 7
Physical Resistance/Sticking 6 6
Incomplete or Inadequate Connection 5 5
Material Integrity Problem 5 5
No Flow 4 4
Difficult to Open or Close 4 4
Unintended Deflation 4 4
Material Split, Cut or Torn 4 4
Therapeutic or Diagnostic Output Failure 4 4
Failure to Deliver 4 4
Loose or Intermittent Connection 4 4
Mechanical Problem 3 3
Disconnection 3 3
Crack 3 3
Material Puncture/Hole 3 3
Use of Device Problem 3 3
Fluid/Blood Leak 3 3
Fitting Problem 3 3
Material Deformation 3 3
Packaging Problem 2 2
Device Handling Problem 2 2
Material Twisted/Bent 2 2
Infusion or Flow Problem 2 2
Material Separation 2 2
Inadequacy of Device Shape and/or Size 2 2
Tear, Rip or Hole in Device Packaging 2 2
Failure to Disconnect 2 2
Incomplete or Missing Packaging 1 1
Obstruction of Flow 1 1
Structural Problem 1 1
Expiration Date Error 1 1
Unexpected Therapeutic Results 1 1
Product Quality Problem 1 1
Material Too Rigid or Stiff 1 1
Improper or Incorrect Procedure or Method 1 1
Suction Problem 1 1
Device Alarm System 1 1
Failure to Deliver Energy 1 1
Complete Blockage 1 1
Collapse 1 1
Contamination 1 1
Misconnection 1 1
Moisture Damage 1 1
Nonstandard Device 1 1
No Device Output 1 1
Increase in Pressure 1 1
Incorrect Measurement 1 1
Leak/Splash 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Mechanical Jam 1 1
No Pressure 1 1
Optical Distortion 1 1
Output Problem 1 1
Device Dislodged or Dislocated 1 1
Improper Flow or Infusion 1 1
Activation, Positioning or Separation Problem 1 1
Device Markings/Labelling Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Patient Device Interaction Problem 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Failure to Seal 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 Clinical Signs, Symptoms or Conditions 45 45
No Known Impact Or Consequence To Patient 36 36
Insufficient Information 25 25
Low Oxygen Saturation 18 18
No Consequences Or Impact To Patient 15 15
Cardiac Arrest 14 14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
No Patient Involvement 10 10
Decreased Respiratory Rate 5 5
Respiratory Arrest 4 4
Respiratory Insufficiency 4 4
Death 4 4
Hypoxia 4 4
Loss of consciousness 3 3
Respiratory Failure 2 2
Bradycardia 2 2
Hypoventilation 2 2
Vomiting 2 2
Unspecified Respiratory Problem 2 2
Cerebral Edema 2 2
No Code Available 2 2
Missing Value Reason 1 1
No Information 1 1
Diminished Pulse Pressure 1 1
Foreign Body In Patient 1 1
Asystole 1 1
Cardiovascular Insufficiency 1 1
Unspecified Tissue Injury 1 1
Anemia 1 1
Failure of Implant 1 1
Pneumothorax 1 1
Respiratory Distress 1 1
Dyspnea 1 1
Endocarditis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 SunMed Holdings, LLC II Nov-21-2023
2 Vyaire Medical I Feb-25-2024
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