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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
AMBU A/S
  SUBSTANTIALLY EQUIVALENT 1
ARCHEON
  SUBSTANTIALLY EQUIVALENT 1
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
2016 92 92
2017 56 56
2018 56 56
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
Break 39 39
Device Issue 31 31
Inflation Problem 27 27
Separation Failure 21 21
Device Operates Differently Than Expected 21 21
Device Operational Issue 20 20
Defective Device 17 17
Deflation Problem 17 17
Difficult to Remove 16 16
Device Damaged Prior to Use 16 16
Defective Component 14 14
Connection Problem 14 14
Appropriate Term/Code Not Available 14 14
Component Missing 12 12
Gas/Air Leak 11 11
Detachment of Device or Device Component 10 10
Material Integrity Problem 10 10
Pressure Problem 9 9
Fitting Problem 9 9
Disconnection 8 8
Missing Value Reason 8 8
Material Deformation 7 7
No Flow 7 7
Detachment Of Device Component 7 7
Air Leak 7 7
Crack 7 7
Loose or Intermittent Connection 7 7
Inadequacy of Device Shape and/or Size 7 7
Activation, Positioning or Separation Problem 6 6
Failure to Deliver 6 6
Mechanical Problem 6 6
Device Dislodged or Dislocated 6 6
Therapeutic or Diagnostic Output Failure 6 6
Physical Resistance/Sticking 6 6
Incomplete or Inadequate Connection 5 5
Material Split, Cut or Torn 5 5
Manufacturing, Packaging or Shipping Problem 5 5
Sticking 5 5
Material Separation 5 5
Product Quality Problem 5 5
Failure to Disconnect 4 4
Difficult to Open or Close 4 4
Kinked 4 4
Leak/Splash 4 4
Collapse 4 4
Packaging Problem 4 4
Insufficient Information 4 4
Unintended Deflation 4 4
Device Handling Problem 3 3
Torn Material 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Device Alarm System 3 3
Fluid/Blood Leak 3 3
Material Puncture/Hole 3 3
Use of Device Problem 3 3
Incomplete or Missing Packaging 2 2
Tear, Rip or Hole in Device Packaging 2 2
Structural Problem 2 2
Difficult to Open or Remove Packaging Material 2 2
Device Markings/Labelling Problem 2 2
Improper Flow or Infusion 2 2
Nonstandard Device 2 2
Hole In Material 2 2
Melted 2 2
Bent 2 2
Disassembly 2 2
Infusion or Flow Problem 2 2
Material Twisted/Bent 2 2
Mechanical Jam 1 1
Ventilation Problem in Device Environment 1 1
No Apparent Adverse Event 1 1
No Pressure 1 1
Optical Distortion 1 1
Output Problem 1 1
Activation Failure 1 1
Patient Device Interaction Problem 1 1
Suction Failure 1 1
Premature Separation 1 1
Missing Information 1 1
Failure to Seal 1 1
Contamination 1 1
Failure to Deliver Energy 1 1
Fire 1 1
Restricted Flow rate 1 1
Complete Blockage 1 1
Failure To Adhere Or Bond 1 1
Arcing at Paddles 1 1
Misconnection 1 1
Moisture Damage 1 1
No Device Output 1 1
Increase in Pressure 1 1
Incorrect Measurement 1 1
Material Too Rigid or Stiff 1 1
Incorrect Device Or Component Shipped 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Device Displays Incorrect Message 1 1
Patient-Device Incompatibility 1 1
Ambient Temperature Problem 1 1
Expiration Date Error 1 1
Obstruction of Flow 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 148 148
Missing Value Reason 54 54
No Clinical Signs, Symptoms or Conditions 46 46
No Consequences Or Impact To Patient 41 41
Not Applicable 25 25
Insufficient Information 25 25
Low Oxygen Saturation 23 23
No Patient Involvement 19 19
Cardiac Arrest 16 16
No Information 14 14
Death 13 13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
No Code Available 10 10
Hypoxia 9 9
Decreased Respiratory Rate 5 5
Respiratory Arrest 4 4
Respiratory Insufficiency 4 4
Loss of consciousness 3 3
Unspecified Respiratory Problem 2 2
Cerebral Edema 2 2
Respiratory Failure 2 2
Vomiting 2 2
Dyspnea 2 2
Low Blood Pressure/ Hypotension 2 2
Hypoventilation 2 2
Bradycardia 2 2
Anemia 1 1
Cardiopulmonary Arrest 1 1
Endocarditis 1 1
Weakness 1 1
Brain Injury 1 1
Fracture, Arm 1 1
Failure of Implant 1 1
Pneumothorax 1 1
Respiratory Distress 1 1
Seizures 1 1
Burn, Thermal 1 1
Diminished Pulse Pressure 1 1
Asystole 1 1
Cardiovascular Insufficiency 1 1
Unspecified Tissue Injury 1 1
Foreign Body In Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Sun Med, LLC II Jun-09-2018
2 SunMed Holdings, LLC II Nov-21-2023
3 Vyaire Medical I Feb-25-2024
4 Vyaire Medical I Aug-08-2018
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