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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)
Product CodeBTL
Regulation Number 868.5925
Device Class 2


Premarket Reviews
ManufacturerDecision
INTERNATIONAL BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MAGNAMED TECNOLOGIA MEDICA S/A
  SUBSTANTIALLY EQUIVALENT 1
VENTLAB, LLC
  SUBSTANTIALLY EQUIVALENT 1
VORTRAN MEDICAL TECHNOLOGY 1, INC.
  SUBSTANTIALLY EQUIVALENT 1
WEINMANN EMERGENCY MEDICAL TECHNOLOGY GMBH + CO. KG
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 197 197
2019 342 342
2020 454 454
2021 508 508
2022 756 756
2023 331 331

Device Problems MDRs with this Device Problem Events in those MDRs
Break 520 520
Pressure Problem 465 465
Device Alarm System 216 216
Failure to Cycle 137 137
Mechanical Problem 115 115
Tidal Volume Fluctuations 103 103
Defective Component 101 101
Loose or Intermittent Connection 76 76
Output Problem 71 71
No Audible Alarm 68 68
Component Missing 67 67
Defective Device 65 65
Gas/Air Leak 63 63
Defective Alarm 52 52
Noise, Audible 48 48
Leak/Splash 47 47
Battery Problem 39 39
Infusion or Flow Problem 38 38
Power Problem 37 37
Incorrect, Inadequate or Imprecise Result or Readings 34 34
Failure to Power Up 33 33
Connection Problem 33 33
Calibration Problem 27 27
Decrease in Pressure 26 26
Crack 26 26
Physical Resistance/Sticking 26 26
Device Fell 26 26
Therapeutic or Diagnostic Output Failure 25 25
Increase in Pressure 25 25
Failure to Deliver 23 23
Detachment of Device or Device Component 22 22
Improper Flow or Infusion 21 21
No Flow 20 20
Display or Visual Feedback Problem 20 20
Electrical /Electronic Property Problem 18 18
Device Sensing Problem 18 18
Unable to Obtain Readings 18 18
Volume Accuracy Problem 15 15
Material Twisted/Bent 15 15
Use of Device Problem 14 14
False Alarm 13 13
No Pressure 13 13
Insufficient Information 13 13
Appropriate Term/Code Not Available 12 12
Device Handling Problem 12 12
Intermittent Loss of Power 12 12
Disconnection 12 12
Gas Output Problem 12 12
Excess Flow or Over-Infusion 11 11
Fracture 11 11
Device Damaged Prior to Use 11 11
Obstruction of Flow 11 11
Mechanical Jam 11 11
Failure of Device to Self-Test 11 11
No Apparent Adverse Event 10 10
Alarm Not Visible 9 9
Loss of or Failure to Bond 9 9
Fluid/Blood Leak 8 8
Device Issue 8 8
Failure to Calibrate 7 7
Failure to Shut Off 7 7
Material Fragmentation 7 7
Inaccurate Flow Rate 7 7
Gel Leak 6 6
Failure to Run on Battery 6 6
Free or Unrestricted Flow 6 6
Manufacturing, Packaging or Shipping Problem 6 6
Medical Gas Supply Problem 6 6
Device Operates Differently Than Expected 6 6
Insufficient Flow or Under Infusion 6 6
Key or Button Unresponsive/not Working 6 6
Output below Specifications 5 5
Ventilation Problem in Device Environment 5 5
Protective Measures Problem 5 5
Unexpected Shutdown 5 5
Audible Prompt/Feedback Problem 5 5
Inaccurate Delivery 5 5
Electromagnetic Compatibility Problem 5 5
Human-Device Interface Problem 5 5
Inflation Problem 5 5
Misassembled 5 5
Device Maintenance Issue 4 4
Incorrect Measurement 4 4
Labelling, Instructions for Use or Training Problem 4 4
Image Display Error/Artifact 4 4
Failure to Sense 4 4
Circuit Failure 4 4
Device Misassembled During Manufacturing /Shipping 4 4
High Readings 4 4
Low Readings 4 4
Failure to Align 4 4
Dent in Material 4 4
No Audible Prompt/Feedback 4 4
Complete Loss of Power 4 4
Incomplete or Inadequate Connection 4 4
Separation Problem 4 4
Material Split, Cut or Torn 3 3
Firing Problem 3 3
Premature Indicator Activation 3 3
Unintended Movement 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1422 1422
No Patient Involvement 293 293
No Known Impact Or Consequence To Patient 287 287
No Information 267 267
Insufficient Information 228 228
No Consequences Or Impact To Patient 167 167
Low Oxygen Saturation 13 13
Patient Problem/Medical Problem 9 9
Apnea 6 6
Hypoxia 5 5
Cardiac Arrest 4 4
Death 4 4
Not Applicable 3 3
Hypoventilation 3 3
Respiratory Insufficiency 2 2
Respiratory Failure 2 2
Decreased Respiratory Rate 2 2
Cardiopulmonary Arrest 2 2
Respiratory Distress 2 2
Ventilator Dependent 2 2
Overinflation of Lung 1 1
Respiratory Tract Infection 1 1
Complaint, Ill-Defined 1 1
Inadequate Pain Relief 1 1
Respiratory Distress Syndrome of Newborns 1 1
Sepsis 1 1
Ischemia 1 1
Asphyxia 1 1
Asthma 1 1
Bacterial Infection 1 1
Air Embolism 1 1
Airway Obstruction 1 1
Sleep Dysfunction 1 1
High Oxygen Saturation 1 1
Unspecified Respiratory Problem 1 1
No Code Available 1 1
Missing Value Reason 1 1
Unspecified Blood or Lymphatic problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 O-Two Medical Technologies, Inc. I Apr-04-2019
2 Precision Valve & Automation,Inc II Aug-14-2020
3 Smiths Medical ASD Inc. III Oct-22-2021
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