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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
MAGNAMED TECNOLOGIA MEDICA S/A
  SUBSTANTIALLY EQUIVALENT 1
VORTRAN MEDICAL TECHNOLOGY 1, INC.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K202219  VORTRAN GO2VENT with PEEP Valve
WEINMANN EMERGENCY MEDICAL TECHNOLOGY GMBH + CO. KG
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 454 454
2021 506 506
2022 755 755
2023 731 731
2024 667 667
2025 49 49

Device Problems MDRs with this Device Problem Events in those MDRs
Pressure Problem 646 646
Break 554 554
Device Alarm System 236 236
Failure to Cycle 194 194
Gas/Air Leak 141 141
Mechanical Problem 123 123
Tidal Volume Fluctuations 102 102
Defective Component 96 96
Loose or Intermittent Connection 96 96
Detachment of Device or Device Component 81 81
Defective Device 75 75
Component Missing 66 66
No Audible Alarm 62 62
Defective Alarm 60 60
Battery Problem 57 57
Crack 54 54
Incorrect, Inadequate or Imprecise Result or Readings 53 53
Fracture 52 52
Noise, Audible 47 47
Inaccurate Delivery 45 45
Output Problem 40 40
Insufficient Information 39 39
Power Problem 38 38
Leak/Splash 37 37
Connection Problem 35 35
Failure to Power Up 35 35
Unable to Obtain Readings 28 28
Improper Flow or Infusion 27 27
Infusion or Flow Problem 27 27
Key or Button Unresponsive/not Working 27 27
Failure to Deliver 27 27
Increase in Pressure 26 26
Device Fell 25 25
Display or Visual Feedback Problem 24 24
Calibration Problem 24 24
Decrease in Pressure 23 23
Gas Output Problem 22 22
Volume Accuracy Problem 21 21
No Flow 21 21
Inaccurate Flow Rate 21 21
Therapeutic or Diagnostic Output Failure 20 20
Electrical /Electronic Property Problem 19 19
Device Difficult to Maintain 19 19
Device Damaged Prior to Use 17 17
No Pressure 17 17
Physical Resistance/Sticking 16 16
Disconnection 16 16
Device Sensing Problem 15 15
Failure of Device to Self-Test 14 14
Free or Unrestricted Flow 13 13

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2330 2330
Insufficient Information 557 557
No Information 181 181
No Patient Involvement 164 164
No Consequences Or Impact To Patient 90 90
No Known Impact Or Consequence To Patient 44 44
Low Oxygen Saturation 12 12
Hypoventilation 7 7
Cardiac Arrest 5 5
Pneumothorax 4 4
Respiratory Arrest 4 4
Hypoxia 4 4
Bradycardia 2 2
Respiratory Insufficiency 2 2
Ventilator Dependent 2 2
Decreased Respiratory Rate 2 2
Air Embolism 1 1
Cyanosis 1 1
Sleep Dysfunction 1 1
Patient Problem/Medical Problem 1 1
Pulmonary Hypertension 1 1
Apnea 1 1
Respiratory Distress 1 1
Sepsis 1 1
Ischemia 1 1
Pleural Empyema 1 1
Asthma 1 1
Low Cardiac Output 1 1
Unspecified Blood or Lymphatic problem 1 1
Overinflation of Lung 1 1
Hyperventilation 1 1
Unspecified Respiratory Problem 1 1
Respiratory Distress Syndrome of Newborns 1 1
Airway Obstruction 1 1
Respiratory Failure 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Mercury Enterprises, Inc. dba Mercury Medical I Jan-10-2025
2 Mercury Enterprises, Inc. dba Mercury Medical I Oct-02-2024
3 Precision Valve & Automation,Inc II Aug-14-2020
4 Smiths Medical ASD Inc. I Sep-20-2024
5 Smiths Medical ASD Inc. I Sep-11-2024
6 Smiths Medical ASD Inc. I Mar-19-2024
7 Smiths Medical ASD Inc. III Oct-22-2021
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