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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
AMBU INTERNATIONAL A/S
  SUBSTANTIALLY EQUIVALENT 1
FOREMOUNT ENTERPRISE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 91 91
2017 56 56
2018 53 53
2019 46 46
2020 26 26

Device Problems MDRs with this Device Problem Events in those MDRs
Device Issue 31 31
Break 28 28
Separation Failure 21 21
Device Operates Differently Than Expected 21 21
Device Operational Issue 19 19
Inflation Problem 16 16
Device Damaged Prior to Use 16 16
Difficult to Remove 15 15
Appropriate Term/Code Not Available 14 14
Bag 13 13
Defective Component 12 12
Connection Problem 12 12
Defective Device 11 11
Deflation Problem 9 9
Component Missing 9 9
Tube 8 8
Missing Value Reason 8 8
Fitting Problem 8 8
Valve(s) 7 7
Detachment Of Device Component 6 6
Disconnection 6 6
Material Deformation 6 6
Air Leak 6 6
Activation, Positioning or SeparationProblem 6 6
Material Separation 5 5
Crack 5 5
Device Dislodged or Dislocated 5 5
Material Integrity Problem 5 5
Inadequacy of Device Shape and/or Size 5 5
Sticking 5 5
Loose or Intermittent Connection 5 5
Kinked 4 4
Leak/Splash 4 4
Product Quality Problem 4 4
Failure to Disconnect 4 4
Manufacturing, Packaging or Shipping Problem 4 4
No Flow 4 4
Mechanical Problem 4 4
Collapse 3 3
Detachment of Device or Device Component 3 3
Torn Material 3 3
Insufficient Information 3 3
Port 3 3
Device Alarm System 2 2
Device Markings/Labelling Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Hole In Material 2 2
Packaging Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Difficult to Open or Close 2 2
Difficult to Open or Remove Packaging Material 2 2
Disassembly 2 2
Incomplete or Missing Packaging 2 2
Failure to Deliver 2 2
Melted 2 2
Bent 2 2
Seal 1 1
Arcing at Paddles 1 1
Valve, Flap 1 1
Heads 1 1
Ring 1 1
Nonstandard Device 1 1
Material Puncture/Hole 1 1
Complete Blockage 1 1
Structural Problem 1 1
Expiration Date Error 1 1
Fire 1 1
Shipping Damage or Problem 1 1
Patient-Device Incompatibility 1 1
No Apparent Adverse Event 1 1
Gas Leak 1 1
Improper Flow or Infusion 1 1
Mechanical Jam 1 1
Patient Device Interaction Problem 1 1
Material Split, Cut or Torn 1 1
No Pressure 1 1
Optical Distortion 1 1
Pressure Problem 1 1
Ventilation Problem in Device Environment 1 1
Device Subassembly 1 1
Incomplete or Inadequate Connection 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Incorrect Device Or Component Shipped 1 1
Device Displays Incorrect Message 1 1
Invalid Sensing 1 1
Failure To Adhere Or Bond 1 1
Restricted Flow rate 1 1
Connector 1 1
Label 1 1
Improper or Incorrect Procedure or Method 1 1
Misconnection 1 1
Moisture Damage 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 Code Available 10 10
Low Oxygen Saturation 7 7
Hypoxia 5 5
Cardiac Arrest 3 3
Low Blood Pressure/ Hypotension 2 2
Hypoventilation 1 1
Cardiopulmonary Arrest 1 1
Dyspnea 1 1
Fracture, Arm 1 1
Insufficient Information 1 1
Respiratory Distress 1 1
Seizures 1 1
Brain Injury 1 1
Burn, Thermal 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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