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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 523 523

Device Problems MDRs with this Device Problem Events in those MDRs
Break 791 791
Pressure Problem 736 736
Device Alarm System 275 275
Failure to Cycle 210 210
Tidal Volume Fluctuations 143 143
Mechanical Problem 139 139
Defective Component 125 125
Gas/Air Leak 124 124
Loose or Intermittent Connection 97 97
Component Missing 95 95
No Audible Alarm 83 83
Detachment of Device or Device Component 82 82
Defective Device 78 78
Device Issue 75 75
Defective Alarm 73 73
Output Problem 73 73
Battery Problem 70 70
Noise, Audible 68 68
Crack 68 68
Incorrect, Inadequate or Imprecise Result or Readings 60 60
Fracture 54 54
Leak/Splash 51 51
Infusion or Flow Problem 48 48
Power Problem 46 46
Connection Problem 43 43
Failure to Power Up 40 40
Device Operates Differently Than Expected 38 38
Calibration Problem 37 37
Insufficient Information 36 36
Increase in Pressure 35 35
Failure to Deliver 34 34
Decrease in Pressure 33 33
Improper Flow or Infusion 32 32
Device Handling Problem 32 32
Unable to Obtain Readings 31 31
Device Fell 29 29
No Flow 28 28
Physical Resistance/Sticking 27 27
Display or Visual Feedback Problem 27 27
Key or Button Unresponsive/not Working 27 27
Gas Output Problem 26 26
Electrical /Electronic Property Problem 25 25
Therapeutic or Diagnostic Output Failure 25 25
Device Damaged Prior to Use 21 21
Volume Accuracy Problem 20 20
Device Difficult to Maintain 19 19
No Pressure 19 19
Disconnection 19 19
Inaccurate Flow Rate 18 18
Device Sensing Problem 18 18

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2200 2200
Insufficient Information 546 546
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 24 24
Hypoventilation 11 11
Death 10 10
Patient Problem/Medical Problem 9 9
Cardiac Arrest 9 9
Apnea 6 6
Not Applicable 6 6
Hypoxia 6 6
Pneumothorax 4 4
Respiratory Distress 4 4
Respiratory Arrest 4 4
Bradycardia 4 4
Decreased Respiratory Rate 3 3
Low Blood Pressure/ Hypotension 3 3
Cardiopulmonary Arrest 3 3
Ventilator Dependent 2 2
Respiratory Failure 2 2
Complaint, Ill-Defined 2 2
Respiratory Insufficiency 2 2
Respiratory Distress Syndrome of Newborns 2 2
Hyperventilation 2 2
Asphyxia 2 2
Distress 1 1
Airway Obstruction 1 1
Inadequate Pain Relief 1 1
Bacterial Infection 1 1
Unspecified Respiratory Problem 1 1
Anxiety 1 1
Missing Value Reason 1 1
Overinflation of Lung 1 1
Respiratory Tract Infection 1 1
Loss Of Pulse 1 1
Paralysis 1 1
Unspecified Blood or Lymphatic problem 1 1
Respiratory Acidosis 1 1
Chronic Obstructive Pulmonary Disease (COPD) 1 1
Low Cardiac Output 1 1
Asthma 1 1
Resuscitation 1 1
Pleural Empyema 1 1
Ischemia 1 1
Diminished Pulse Pressure 1 1
Sepsis 1 1
No Code Available 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 Sep-20-2024
12 Smiths Medical ASD Inc. I Sep-11-2024
13 Smiths Medical ASD Inc. I Mar-19-2024
14 Smiths Medical ASD Inc. III Oct-22-2021
15 Thornhill Research Inc I Jan-11-2016
16 Vortran Medical Technology 1, Inc II Apr-25-2017
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