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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
DRAEGERWERK AG & CO. KGAA
  SUBSTANTIALLY EQUIVALENT 1
MAGNAMED TECNOLOGIA MEDICA S/A
  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
2020 454 454
2021 506 506
2022 755 755
2023 731 731
2024 667 667
2025 115 115

Device Problems MDRs with this Device Problem Events in those MDRs
Pressure Problem 657 657
Break 555 555
Device Alarm System 238 238
Failure to Cycle 198 198
Gas/Air Leak 146 146
Mechanical Problem 125 125
Tidal Volume Fluctuations 102 102
Loose or Intermittent Connection 98 98
Defective Component 96 96
Detachment of Device or Device Component 84 84
Defective Device 75 75
No Audible Alarm 66 66
Component Missing 66 66
Defective Alarm 61 61
Battery Problem 57 57
Incorrect, Inadequate or Imprecise Result or Readings 54 54
Crack 54 54
Fracture 53 53
Noise, Audible 47 47
Inaccurate Delivery 46 46
Leak/Splash 40 40
Insufficient Information 40 40
Output Problem 40 40
Power Problem 38 38
Connection Problem 36 36
Failure to Power Up 35 35
Calibration Problem 33 33
Improper Flow or Infusion 29 29
Unable to Obtain Readings 28 28
Increase in Pressure 28 28
Key or Button Unresponsive/not Working 27 27
Decrease in Pressure 27 27
Failure to Deliver 27 27
Infusion or Flow Problem 27 27
Display or Visual Feedback Problem 25 25
Device Fell 25 25
Gas Output Problem 24 24
Volume Accuracy Problem 23 23
No Flow 23 23
Inaccurate Flow Rate 21 21
Therapeutic or Diagnostic Output Failure 20 20
Device Difficult to Maintain 19 19
Electrical /Electronic Property Problem 19 19
Device Sensing Problem 18 18
Disconnection 18 18
Device Damaged Prior to Use 17 17
No Pressure 17 17
Physical Resistance/Sticking 16 16
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 2401 2401
Insufficient Information 558 558
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 6 6
Hypoxia 5 5
Pneumothorax 4 4
Respiratory Arrest 4 4
Bradycardia 3 3
Decreased Respiratory Rate 3 3
Respiratory Insufficiency 2 2
Ventilator Dependent 2 2
Respiratory Failure 2 2
Patient Problem/Medical Problem 1 1
Air Embolism 1 1
Sleep Dysfunction 1 1
Cyanosis 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
Unspecified Respiratory Problem 1 1
Hyperventilation 1 1
Respiratory Distress Syndrome of Newborns 1 1
Airway Obstruction 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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