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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

MDR Year MDR Reports MDR Events
2021 506 507
2022 755 757
2023 731 733
2024 667 667
2025 168 168
2026 20 20

Device Problems MDRs with this Device Problem Events in those MDRs
Pressure Problem 587 588
Break 458 459
Failure to Cycle 180 180
Device Alarm System 179 179
Gas/Air Leak 151 151
Mechanical Problem 114 114
Loose or Intermittent Connection 99 99
Tidal Volume Fluctuations 86 86
Detachment of Device or Device Component 80 80
Defective Component 79 79
Defective Device 66 68
Defective Alarm 58 59
Component Missing 56 56
Battery Problem 51 51
Fracture 50 50
Inaccurate Delivery 48 48
Incorrect, Inadequate or Imprecise Result or Readings 46 46
Noise, Audible 45 45
No Audible Alarm 44 44
Crack 43 43
Insufficient Information 38 38
Leak/Splash 35 35
Connection Problem 32 32
Output Problem 31 31
Calibration Problem 29 29
Key or Button Unresponsive/not Working 28 28
Unable to Obtain Readings 28 28
Failure to Deliver 27 27
Power Problem 27 27
Decrease in Pressure 27 27
Failure to Power Up 26 26
Display or Visual Feedback Problem 25 25
Gas Output Problem 23 23
Improper Flow or Infusion 23 23
Volume Accuracy Problem 22 22
Inaccurate Flow Rate 21 21
Device Fell 19 19
Device Difficult to Maintain 19 19
Free or Unrestricted Flow 19 19
Increase in Pressure 19 19
Infusion or Flow Problem 18 18
Device Sensing Problem 18 18
No Pressure 17 17
Electrical /Electronic Property Problem 17 17
No Flow 17 17
Disconnection 16 16
Device Damaged Prior to Use 14 14
Therapeutic or Diagnostic Output Failure 14 14
Insufficient Flow or Under Infusion 13 13
Physical Resistance/Sticking 12 12

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2409 2412
Insufficient Information 558 560
No Information 28 28
No Patient Involvement 19 19
Low Oxygen Saturation 11 11
Hypoventilation 7 7
Pneumothorax 4 4
Respiratory Arrest 4 4
Cardiac Arrest 4 4
Hypoxia 4 4
No Consequences Or Impact To Patient 4 4
Bradycardia 3 3
Decreased Respiratory Rate 3 3
Respiratory Insufficiency 2 2
Respiratory Failure 2 2
Sleep Dysfunction 1 1
Cyanosis 1 1
Pulmonary Hypertension 1 1
Apnea 1 1
Sepsis 1 1
Ischemia 1 1
Pleural Empyema 1 1
Low Cardiac Output 1 1
Unspecified Blood or Lymphatic problem 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 Smiths Medical ASD Inc. I Sep-20-2024
4 Smiths Medical ASD Inc. I Sep-11-2024
5 Smiths Medical ASD Inc. I Mar-19-2024
6 Smiths Medical ASD Inc. III Oct-22-2021
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