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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 755 757
2023 731 731
2024 667 667
2025 157 157

Device Problems MDRs with this Device Problem Events in those MDRs
Pressure Problem 664 664
Break 555 555
Device Alarm System 240 240
Failure to Cycle 202 202
Gas/Air Leak 148 148
Mechanical Problem 125 125
Loose or Intermittent Connection 103 103
Tidal Volume Fluctuations 102 102
Defective Component 96 96
Detachment of Device or Device Component 84 84
Defective Device 75 77
No Audible Alarm 68 68
Component Missing 66 66
Defective Alarm 61 61
Battery Problem 57 57
Incorrect, Inadequate or Imprecise Result or Readings 55 55
Crack 54 54
Fracture 53 53
Inaccurate Delivery 48 48
Noise, Audible 47 47
Leak/Splash 43 43
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 32 32
Increase in Pressure 29 29
Unable to Obtain Readings 28 28
Failure to Deliver 28 28
Infusion or Flow Problem 27 27
Decrease in Pressure 27 27
Key or Button Unresponsive/not Working 27 27
Gas Output Problem 26 26
No Flow 26 26
Display or Visual Feedback Problem 25 25
Device Fell 25 25
Volume Accuracy Problem 23 23
Inaccurate Flow Rate 21 21
Device Sensing Problem 20 20
Therapeutic or Diagnostic Output Failure 20 20
Electrical /Electronic Property Problem 19 19
Device Difficult to Maintain 19 19
Disconnection 18 18
Free or Unrestricted Flow 17 17
Device Damaged Prior to Use 17 17
No Pressure 17 17
Physical Resistance/Sticking 16 16
Failure of Device to Self-Test 14 14

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2444 2444
Insufficient Information 558 560
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
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

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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