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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
ALLIED HEALTHCARE PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 5
ATOM MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
AUTOMEDX INC.
  SUBSTANTIALLY EQUIVALENT 1
DOLPHYS MEDICAL B.V.
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 2
MAGNAMED TECNOLOGIA MEDICA S/A
  SUBSTANTIALLY EQUIVALENT 1
MERCURY MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MERCURY MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEOFORCE GROUP, INC.
  SUBSTANTIALLY EQUIVALENT 1
O-TWO MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
SMITHS MEDICAL INTERNATIONAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
THORNHILL RESEARCH INC
  SUBSTANTIALLY EQUIVALENT 2
THORNHILL RESEARCH INC.
  SUBSTANTIALLY EQUIVALENT 1
VBM MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 1
VENTLAB, LLC
  SUBSTANTIALLY EQUIVALENT 1
VORTRAN MEDICAL TECHNOLOGY 1, INC.
  SUBSTANTIALLY EQUIVALENT 2
WEINMANN EMERGENCY MEDICAL TECHNOLOGY GMBH + CO. KG
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 69 69
2015 79 79
2016 80 80
2017 101 101
2018 197 197
2019 341 341
2020 454 454
2021 506 506
2022 755 755
2023 787 787
2024 327 327

Device Problems MDRs with this Device Problem Events in those MDRs
Break 760 760
Pressure Problem 696 696
Device Alarm System 260 260
Failure to Cycle 198 198
Tidal Volume Fluctuations 138 138
Mechanical Problem 137 137
Defective Component 114 114
Gas/Air Leak 104 104
Loose or Intermittent Connection 95 95
Component Missing 89 89
No Audible Alarm 78 78
Device Issue 75 75
Defective Device 74 74
Detachment of Device or Device Component 73 73
Output Problem 73 73
Defective Alarm 70 70
Crack 66 66
Noise, Audible 64 64
Battery Problem 58 58
Incorrect, Inadequate or Imprecise Result or Readings 53 53
Leak/Splash 50 50
Infusion or Flow Problem 47 47
Power Problem 46 46
Fracture 46 46
Connection Problem 42 42
Failure to Power Up 40 40
Device Operates Differently Than Expected 38 38
Increase in Pressure 35 35
Calibration Problem 33 33
Failure to Deliver 33 33
Decrease in Pressure 33 33
Device Handling Problem 32 32
Improper Flow or Infusion 30 30
Unable to Obtain Readings 30 30
Device Fell 29 29
Insufficient Information 29 29
No Flow 28 28
Physical Resistance/Sticking 27 27
Key or Button Unresponsive/not Working 26 26
Gas Output Problem 26 26
Electrical /Electronic Property Problem 25 25
Therapeutic or Diagnostic Output Failure 25 25
Display or Visual Feedback Problem 24 24
Device Damaged Prior to Use 20 20
Volume Accuracy Problem 19 19
Disconnection 19 19
No Pressure 19 19
Device Sensing Problem 18 18
Device Difficult to Maintain 17 17
Failure of Device to Self-Test 16 16
Material Twisted/Bent 16 16
Inaccurate Flow Rate 16 16
False Alarm 15 15
Free or Unrestricted Flow 15 15
Alarm Not Visible 14 14
Use of Device Problem 14 14
Material Separation 13 13
Excess Flow or Over-Infusion 13 13
Appropriate Term/Code Not Available 13 13
Intermittent Loss of Power 12 12
Mechanical Jam 12 12
Failure to Run on Battery 12 12
Loss of or Failure to Bond 12 12
Device Inoperable 12 12
Obstruction of Flow 11 11
Circuit Failure 11 11
No Device Output 11 11
Fluid/Blood Leak 11 11
Device Maintenance Issue 10 10
Failure to Calibrate 10 10
No Apparent Adverse Event 10 10
Physical Property Issue 10 10
Material Deformation 9 9
Inaccurate Delivery 9 9
Material Fragmentation 9 9
Device Operational Issue 8 8
Medical Gas Supply Problem 8 8
Failure to Shut Off 8 8
Separation Problem 8 8
Adverse Event Without Identified Device or Use Problem 7 7
Unexpected Shutdown 7 7
Audible Prompt/Feedback Problem 7 7
Insufficient Flow or Under Infusion 7 7
Failure to Sense 6 6
Gel Leak 6 6
Misassembled 6 6
Loss of Power 6 6
Failure to Charge 6 6
Unintended Movement 6 6
Ventilation Problem in Device Environment 6 6
Output below Specifications 6 6
Material Integrity Problem 6 6
Manufacturing, Packaging or Shipping Problem 6 6
Incomplete or Inadequate Connection 6 6
Misassembly During Maintenance/Repair 5 5
Electromagnetic Compatibility Problem 5 5
Human-Device Interface Problem 5 5
Protective Measures Problem 5 5
Detachment Of Device Component 5 5
Labelling, Instructions for Use or Training Problem 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2011 2011
Insufficient Information 532 532
No Patient Involvement 421 421
No Known Impact Or Consequence To Patient 392 392
No Information 276 276
No Consequences Or Impact To Patient 215 215
Low Oxygen Saturation 23 23
Hypoventilation 11 11
Death 10 10
Cardiac Arrest 9 9
Patient Problem/Medical Problem 9 9
Not Applicable 6 6
Apnea 6 6
Hypoxia 5 5
Pneumothorax 4 4
Respiratory Distress 4 4
Bradycardia 4 4
Low Blood Pressure/ Hypotension 3 3
Decreased Respiratory Rate 3 3
Cardiopulmonary Arrest 3 3
Asphyxia 2 2
Respiratory Distress Syndrome of Newborns 2 2
Ventilator Dependent 2 2
Complaint, Ill-Defined 2 2
Respiratory Arrest 2 2
Respiratory Insufficiency 2 2
Respiratory Failure 2 2
Unspecified Respiratory Problem 1 1
High Oxygen Saturation 1 1
Respiratory Acidosis 1 1
No Code Available 1 1
Missing Value Reason 1 1
Unspecified Blood or Lymphatic problem 1 1
Pleural Empyema 1 1
Pulmonary Hypertension 1 1
Inadequate Pain Relief 1 1
Chronic Obstructive Pulmonary Disease (COPD) 1 1
Anxiety 1 1
Distress 1 1
Overinflation of Lung 1 1
Resuscitation 1 1
Respiratory Tract Infection 1 1
Low Cardiac Output 1 1
Sleep Dysfunction 1 1
Loss Of Pulse 1 1
Diminished Pulse Pressure 1 1
Sepsis 1 1
Ischemia 1 1
Paralysis 1 1
Hyperventilation 1 1
Cyanosis 1 1
Asthma 1 1
Bacterial Infection 1 1
Air Embolism 1 1
Airway Obstruction 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Draeger Medical Systems, Inc. I Apr-10-2014
2 GE Healthcare II Feb-03-2014
3 GE Healthcare, LLC I Feb-25-2014
4 GE Healthcare, LLC I Feb-08-2013
5 GE Healthcare, LLC I Dec-26-2012
6 Impact Instrumentation, Inc. II Jun-26-2015
7 Instrumentation Industries Inc II Apr-16-2013
8 Mercury Enterprises, Inc. dba Mercury Medical II Jan-12-2016
9 O-Two Medical Technologies, Inc. I Apr-04-2019
10 Precision Valve & Automation,Inc II Aug-14-2020
11 Smiths Medical ASD Inc. I Mar-19-2024
12 Smiths Medical ASD Inc. III Oct-22-2021
13 Thornhill Research Inc I Jan-11-2016
14 Vortran Medical Technology 1, Inc II Apr-25-2017
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