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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
VORTRAN MEDICAL TECHNOLOGY 1, INC.
  SUBSTANTIALLY EQUIVALENT 1
WEINMANN EMERGENCY MEDICAL TECHNOLOGY GMBH + CO. KG
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 341 341
2020 454 454
2021 506 506
2022 755 755
2023 787 787
2024 523 523

Device Problems MDRs with this Device Problem Events in those MDRs
Pressure Problem 712 712
Break 656 656
Device Alarm System 261 261
Failure to Cycle 205 205
Tidal Volume Fluctuations 134 134
Mechanical Problem 133 133
Gas/Air Leak 118 118
Defective Component 113 113
Loose or Intermittent Connection 89 89
Component Missing 82 82
Detachment of Device or Device Component 81 81
No Audible Alarm 78 78
Defective Device 76 76
Battery Problem 66 66
Defective Alarm 66 66
Noise, Audible 63 63
Incorrect, Inadequate or Imprecise Result or Readings 59 59
Output Problem 58 58
Crack 55 55
Fracture 54 54
Leak/Splash 44 44
Power Problem 43 43
Failure to Power Up 39 39
Connection Problem 38 38
Calibration Problem 36 36
Infusion or Flow Problem 31 31
Insufficient Information 30 30
Increase in Pressure 30 30
Unable to Obtain Readings 29 29
Improper Flow or Infusion 28 28
Decrease in Pressure 28 28
Display or Visual Feedback Problem 27 27
Failure to Deliver 27 27
Key or Button Unresponsive/not Working 27 27
Device Fell 26 26
Therapeutic or Diagnostic Output Failure 25 25
Gas Output Problem 23 23
Electrical /Electronic Property Problem 22 22
No Flow 21 21
Physical Resistance/Sticking 21 21
Volume Accuracy Problem 20 20
Device Difficult to Maintain 19 19
Device Sensing Problem 18 18
Inaccurate Flow Rate 17 17
Device Damaged Prior to Use 17 17
No Pressure 15 15
False Alarm 15 15
Disconnection 15 15
Failure of Device to Self-Test 14 14
Alarm Not Visible 14 14

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2200 2200
Insufficient Information 546 546
No Information 254 254
No Patient Involvement 247 247
No Known Impact Or Consequence To Patient 174 174
No Consequences Or Impact To Patient 153 153
Low Oxygen Saturation 13 13
Patient Problem/Medical Problem 8 8
Apnea 6 6
Cardiac Arrest 6 6
Hypoxia 6 6
Pneumothorax 4 4
Respiratory Arrest 4 4
Hypoventilation 3 3
Respiratory Insufficiency 2 2
Ventilator Dependent 2 2
Decreased Respiratory Rate 2 2
Air Embolism 1 1
Sleep Dysfunction 1 1
Cyanosis 1 1
Pulmonary Hypertension 1 1
High Oxygen Saturation 1 1
Not Applicable 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
Respiratory Tract Infection 1 1
Asphyxia 1 1
Overinflation of Lung 1 1
Unspecified Respiratory Problem 1 1
Hyperventilation 1 1
Bacterial Infection 1 1
Inadequate Pain Relief 1 1
Respiratory Distress Syndrome of Newborns 1 1
Airway Obstruction 1 1
Respiratory Failure 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. 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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