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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 234 234

Device Problems MDRs with this Device Problem Events in those MDRs
Break 742 742
Pressure Problem 674 674
Device Alarm System 255 255
Failure to Cycle 190 190
Mechanical Problem 137 137
Tidal Volume Fluctuations 132 132
Defective Component 114 114
Gas/Air Leak 94 94
Loose or Intermittent Connection 93 93
Component Missing 85 85
No Audible Alarm 77 77
Device Issue 75 75
Output Problem 73 73
Defective Device 72 72
Detachment of Device or Device Component 68 68
Defective Alarm 67 67
Crack 62 62
Noise, Audible 62 62
Battery Problem 58 58
Incorrect, Inadequate or Imprecise Result or Readings 52 52
Leak/Splash 50 50
Power Problem 46 46
Infusion or Flow Problem 46 46
Fracture 42 42
Connection Problem 42 42
Failure to Power Up 40 40
Device Operates Differently Than Expected 38 38
Increase in Pressure 35 35
Decrease in Pressure 33 33
Calibration Problem 33 33
Device Handling Problem 32 32
Failure to Deliver 31 31
Unable to Obtain Readings 30 30
Device Fell 29 29
Improper Flow or Infusion 29 29
No Flow 27 27
Insufficient Information 27 27
Physical Resistance/Sticking 27 27
Key or Button Unresponsive/not Working 26 26
Therapeutic or Diagnostic Output Failure 25 25
Gas Output Problem 25 25
Electrical /Electronic Property Problem 25 25
Display or Visual Feedback Problem 23 23
Device Damaged Prior to Use 20 20
Volume Accuracy Problem 19 19
Device Sensing Problem 18 18
Disconnection 18 18
No Pressure 18 18
Device Difficult to Maintain 17 17
Material Twisted/Bent 16 16
Failure of Device to Self-Test 16 16
False Alarm 15 15
Inaccurate Flow Rate 15 15
Alarm Not Visible 14 14
Use of Device Problem 14 14
Free or Unrestricted Flow 14 14
Appropriate Term/Code Not Available 13 13
Material Separation 13 13
Device Inoperable 12 12
Loss of or Failure to Bond 12 12
Failure to Run on Battery 12 12
Intermittent Loss of Power 12 12
Mechanical Jam 12 12
Fluid/Blood Leak 11 11
Excess Flow or Over-Infusion 11 11
Circuit Failure 11 11
Obstruction of Flow 11 11
Failure to Calibrate 10 10
No Device Output 10 10
Device Maintenance Issue 10 10
Physical Property Issue 10 10
No Apparent Adverse Event 10 10
Material Fragmentation 9 9
Inaccurate Delivery 8 8
Device Operational Issue 8 8
Separation Problem 8 8
Medical Gas Supply Problem 8 8
Failure to Shut Off 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
Manufacturing, Packaging or Shipping Problem 6 6
Material Integrity Problem 6 6
Output below Specifications 6 6
Incomplete or Inadequate Connection 6 6
Misassembly During Maintenance/Repair 5 5
Material Deformation 5 5
Human-Device Interface Problem 5 5
Electromagnetic Compatibility 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 1935 1935
Insufficient Information 517 517
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
Bradycardia 4 4
Respiratory Distress 4 4
Low Blood Pressure/ Hypotension 3 3
Cardiopulmonary Arrest 3 3
Decreased Respiratory Rate 3 3
Pneumothorax 3 3
Respiratory Failure 2 2
Respiratory Arrest 2 2
Respiratory Insufficiency 2 2
Complaint, Ill-Defined 2 2
Ventilator Dependent 2 2
Asphyxia 2 2
Respiratory Distress Syndrome of Newborns 2 2
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
Overinflation of Lung 1 1
Resuscitation 1 1
Respiratory Tract Infection 1 1
Chronic Obstructive Pulmonary Disease (COPD) 1 1
Anxiety 1 1
Distress 1 1
Inadequate Pain Relief 1 1
High Oxygen Saturation 1 1
Respiratory Acidosis 1 1
Low Cardiac Output 1 1
Sleep Dysfunction 1 1
Loss Of Pulse 1 1
Diminished Pulse Pressure 1 1
Unspecified Respiratory Problem 1 1
No Code Available 1 1
Missing Value Reason 1 1
Unspecified Blood or Lymphatic problem 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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