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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device ventilator, emergency, powered (resuscitator)
Regulation Description Powered emergency ventilator.
Product CodeBTL
Regulation Number 868.5925
Device Class 2


Premarket Reviews
ManufacturerDecision
INTERNATIONAL BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL BIOMEDICAL, LTD.
  SUBSTANTIALLY EQUIVALENT 1
THORNHILL RESEARCH INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
VENTLAB, LLC
  SUBSTANTIALLY EQUIVALENT 1
VORTRAN MEDICAL TECHNOLOGY 1, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2016 80 80
2017 101 101
2018 197 197
2019 342 342
2020 454 454
2021 36 36

Device Problems MDRs with this Device Problem Events in those MDRs
Break 263 263
Pressure Problem 138 138
Device Alarm System 110 110
Device Issue 69 69
Tidal Volume Fluctuations 67 67
Failure to Cycle 50 50
No Audible Alarm 47 47
Defective Component 44 44
Output Problem 43 43
Component Missing 39 39
Alarm 36 36
Mechanical Problem 34 34
Infusion or Flow Problem 30 30
Device Handling Problem 30 30
Leak/Splash 25 25
Knob 22 22
Noise, Audible 22 22
Device Operates Differently Than Expected 21 21
Increase in Pressure 21 21
Crack 20 20
Calibration Problem 19 19
Decrease in Pressure 19 19
Gas Leak 18 18
Improper Flow or Infusion 18 18
Incorrect, Inadequate or Imprecise Resultor Readings 17 17
Defective Alarm 17 17
Battery Problem 17 17
Power Problem 16 16
Physical Resistance/Sticking 15 15
Failure to Power Up 14 14
No Flow 14 14
Material Twisted/Bent 14 14
Therapeutic or Diagnostic Output Failure 13 13
Loose or Intermittent Connection 13 13
Valve(s) 12 12
Defective Device 12 12
Insufficient Information 11 11
Device Fell 11 11
Connection Problem 10 10
Device Maintenance Issue 10 10
Device Component Or Accessory 10 10
Physical Property Issue 10 10
Use of Device Problem 10 10
Failure to Deliver 9 9
Excess Flow or Over-Infusion 9 9
Appropriate Term/Code Not Available 9 9
No Apparent Adverse Event 9 9
Port 9 9
Control Switches 9 9
Gauges/Meters 9 9
Alarm, Audible 8 8
Electrical /Electronic Property Problem 8 8
Disconnection 7 7
Battery 7 7
Alarm Not Visible 7 7
Device Damaged Prior to Use 7 7
Intermittent Loss of Power 7 7
Gas Output Problem 7 7
Valve, Flow 7 7
Material Fragmentation 6 6
Failure to Calibrate 6 6
Detachment of Device or Device Component 6 6
False Alarm 6 6
Valve, Outlet Port 6 6
Device Inoperable 6 6
Unable to Obtain Readings 5 5
Cover 5 5
Device Sensing Problem 5 5
Free or Unrestricted Flow 5 5
Failure to Shut Off 5 5
Device Operational Issue 5 5
Fracture 5 5
Human-Device Interface Problem 5 5
Protective Measures Problem 4 4
Gas Delivery System 4 4
Labelling, Instructions for Use or Training Problem 4 4
Failure to Align 4 4
Loss of Power 4 4
Inaccurate Delivery 4 4
Medical Gas Supply Problem 4 4
Adverse Event Without Identified Device or Use Problem 4 4
No Pressure 4 4
Failure of Device to Self-Test 4 4
Electromagnetic Compatibility Problem 4 4
Indicator 4 4
Detachment Of Device Component 4 4
Insufficient Flow or Under Infusion 4 4
Inaccurate Flow Rate 4 4
Image Display Error/Artifact 3 3
Misassembled 3 3
Sticking 3 3
Circuit Failure 3 3
Valve, PEEP (Positive End Expiratory Pressure) 3 3
Alarm, Oxygen Pressure 3 3
Dent in Material 3 3
Device Markings/Labelling Problem 3 3
Firing Problem 3 3
Switch, Push Button 3 3
Unintended Movement 3 3
Ventilation Problem in Device Environment 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 364 364
No Known Impact Or Consequence To Patient 321 321
No Information 260 260
No Consequences Or Impact To Patient 192 192
No Clinical Signs, Symptoms or Conditions 81 81
Low Oxygen Saturation 15 15
Patient Problem/Medical Problem 9 9
Death 8 8
Hypoventilation 7 7
Apnea 5 5
Cardiac Arrest 4 4
Hypoxia 4 4
Bradycardia 3 3
Not Applicable 3 3
Cardiopulmonary Arrest 3 3
Low Blood Pressure/ Hypotension 2 2
Respiratory Distress 2 2
Asphyxia 2 2
Complaint, Ill-Defined 2 2
Ventilator Dependent 2 2
Overinflation of Lung 1 1
Respiratory Tract Infection 1 1
High Oxygen Saturation 1 1
Loss Of Pulse 1 1
Diminished Pulse Pressure 1 1
Inadequate Pain Relief 1 1
Hyperventilation 1 1
Respiratory Distress Syndrome of Newborns 1 1
Distress 1 1
Asthma 1 1
Bacterial Infection 1 1
No Code Available 1 1
Missing Value Reason 1 1
Air Embolism 1 1
Respiratory Acidosis 1 1
Respiratory Failure 1 1
Decreased Respiratory Rate 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Mercury Enterprises, Inc. dba Mercury Medical II Jan-12-2016
2 O-Two Medical Technologies, Inc. I Apr-04-2019
3 Precision Valve & Automation,Inc II Aug-14-2020
4 Thornhill Research Inc I Jan-11-2016
5 Vortran Medical Technology 1, Inc II Apr-25-2017
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