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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
  1.  K210288  Disposable Manual Resuscitator

MDR Year MDR Reports MDR Events
2016 92 92
2017 56 56
2018 53 53
2019 46 46
2020 26 26
2021 35 35

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
Inflation Problem 20 20
Device Operational Issue 19 19
Difficult to Remove 16 16
Device Damaged Prior to Use 16 16
Defective Device 15 15
Appropriate Term/Code Not Available 14 14
Connection Problem 14 14
Defective Component 12 12
Component Missing 10 10
Deflation Problem 9 9
Fitting Problem 8 8
Missing Value Reason 8 8
Material Deformation 7 7
Activation, Positioning or SeparationProblem 6 6
Inadequacy of Device Shape and/or Size 6 6
Detachment Of Device Component 6 6
Disconnection 6 6
Air Leak 6 6
Crack 5 5
Material Separation 5 5
Loose or Intermittent Connection 5 5
Sticking 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
Manufacturing, Packaging or Shipping Problem 4 4
Therapeutic or Diagnostic Output Failure 4 4
Product Quality Problem 4 4
Failure to Disconnect 4 4
Kinked 4 4
Leak/Splash 4 4
Mechanical Problem 4 4
Collapse 4 4
Unintended Deflation 3 3
Torn Material 3 3
Failure to Deliver 3 3
Insufficient Information 3 3
Packaging Problem 3 3
Physical Resistance/Sticking 3 3
Adverse Event Without Identified Device or Use Problem 2 2
Device Markings/Labelling Problem 2 2
Material Twisted/Bent 2 2
Device Alarm System 2 2
Bent 2 2
Disassembly 2 2
Melted 2 2
Nonstandard Device 2 2
Material Puncture/Hole 2 2
Hole In Material 2 2
Use of Device Problem 2 2
Incomplete or Missing Packaging 2 2
Difficult to Open or Close 2 2
Difficult to Open or Remove Packaging Material 2 2
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
Fire 1 1
Arcing at Paddles 1 1
Complete Blockage 1 1
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
Mechanical Jam 1 1
Improper Flow or Infusion 1 1
No Apparent Adverse Event 1 1
Patient Device Interaction Problem 1 1
Material Split, Cut or Torn 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 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
Insufficient Information 14 14
No Clinical Signs, Symptoms or Conditions 12 12
Death 12 12
No Code Available 10 10
Cardiac Arrest 8 8
Low Oxygen Saturation 8 8
Hypoxia 5 5
Respiratory Arrest 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Low Blood Pressure/ Hypotension 2 2
Hypoventilation 1 1
Fracture, Arm 1 1
Anemia 1 1
Cardiopulmonary Arrest 1 1
Dyspnea 1 1
Endocarditis 1 1
Asystole 1 1
Cardiovascular Insufficiency 1 1
Respiratory Distress 1 1
Seizures 1 1
Brain Injury 1 1
Burn, Thermal 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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