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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device ventilator, emergency, manual (resuscitator)
Product CodeBTM
Regulation Number 868.5915
Device Class 2


Premarket Reviews
ManufacturerDecision
A PLUS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
AMBU A/S
  SUBSTANTIALLY EQUIVALENT 2
ARCHEON
  SUBSTANTIALLY EQUIVALENT 1
FLEXICARE MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
FOREMOUNT ENTERPRISE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HERSILL, S.L.
  SUBSTANTIALLY EQUIVALENT 1
LAERDAL MEDICAL A/S
  SUBSTANTIALLY EQUIVALENT 1
MICROBVM SYSTEMS LTD
  SUBSTANTIALLY EQUIVALENT 1
NEOFORCE GROUP, INC.
  SUBSTANTIALLY EQUIVALENT 1
SAFE BVM CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
XIAMEN COMPOWER MEDICAL TECH. CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 107 107
2015 36 36
2016 92 92
2017 56 56
2018 56 56
2019 46 46
2020 26 26
2021 42 42
2022 35 35
2023 48 48
2024 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
No Flow 75 75
Failure to Deliver 73 73
Break 46 46
Inflation Problem 31 31
Device Issue 31 31
Device Operates Differently Than Expected 28 28
Device Operational Issue 21 21
Separation Failure 21 21
Defective Device 18 18
Device Damaged Prior to Use 18 18
Deflation Problem 18 18
Detachment Of Device Component 17 17
Disconnection 17 17
Connection Problem 17 17
Defective Component 16 16
Difficult to Remove 16 16
Component Missing 15 15
Appropriate Term/Code Not Available 14 14
Detachment of Device or Device Component 11 11
Gas/Air Leak 11 11
Material Integrity Problem 11 11
Fitting Problem 11 11
Material Separation 9 9
Loose or Intermittent Connection 9 9
Pressure Problem 9 9
Material Deformation 8 8
Device Dislodged or Dislocated 8 8
Missing Value Reason 8 8
Crack 8 8
Air Leak 8 8
Inadequacy of Device Shape and/or Size 7 7
Use of Device Problem 7 7
Mechanical Problem 6 6
Device Handling Problem 6 6
Physical Resistance/Sticking 6 6
Activation, Positioning or Separation Problem 6 6
Insufficient Information 6 6
Therapeutic or Diagnostic Output Failure 6 6
Torn Material 5 5
Manufacturing, Packaging or Shipping Problem 5 5
Incomplete or Inadequate Connection 5 5
Material Split, Cut or Torn 5 5
Hole In Material 5 5
Sticking 5 5
Product Quality Problem 5 5
Leak/Splash 5 5
Kinked 4 4
Collapse 4 4
Unintended Deflation 4 4
Infusion or Flow Problem 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Packaging Problem 4 4
Failure to Disconnect 4 4
Difficult to Open or Close 4 4
Device Markings/Labelling Problem 3 3
Improper Flow or Infusion 3 3
Complete Blockage 3 3
Device Alarm System 3 3
Component Falling 3 3
Fluid/Blood Leak 3 3
Material Puncture/Hole 3 3
Improper or Incorrect Procedure or Method 3 3
Tear, Rip or Hole in Device Packaging 3 3
Incomplete or Missing Packaging 2 2
Device Displays Incorrect Message 2 2
Structural Problem 2 2
Decrease in Pressure 2 2
Increase in Pressure 2 2
Imprecision 2 2
Disassembly 2 2
Melted 2 2
Misconnection 2 2
Nonstandard Device 2 2
Bent 2 2
Improper Device Output 2 2
Device Contamination with Chemical or Other Material 2 2
Difficult to Open or Remove Packaging Material 2 2
Output Problem 2 2
Ventilation Problem in Device Environment 2 2
Material Twisted/Bent 2 2
Mechanical Jam 1 1
No Pressure 1 1
Optical Distortion 1 1
Output below Specifications 1 1
No Apparent Adverse Event 1 1
Delivery System Failure 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Incorrect Device Or Component Shipped 1 1
Failure to Seal 1 1
Suction Failure 1 1
Premature Separation 1 1
Missing Information 1 1
Activation Failure 1 1
Patient Device Interaction Problem 1 1
Failure To Adhere Or Bond 1 1
Arcing at Paddles 1 1
Contamination 1 1
Decoupling 1 1
Failure to Deliver Energy 1 1
Fire 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 250 250
Missing Value Reason 54 54
No Consequences Or Impact To Patient 50 50
No Clinical Signs, Symptoms or Conditions 46 46
Low Oxygen Saturation 29 29
Insufficient Information 25 25
Not Applicable 25 25
No Information 22 22
No Patient Involvement 21 21
Cardiac Arrest 20 20
Death 19 19
Hypoxia 12 12
No Code Available 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
Respiratory Distress 6 6
Decreased Respiratory Rate 5 5
Bradycardia 4 4
Hypoventilation 4 4
Respiratory Arrest 4 4
Respiratory Insufficiency 4 4
Loss of consciousness 3 3
Vomiting 2 2
Brain Injury 2 2
Respiratory Failure 2 2
Foreign Body In Patient 2 2
Confusion/ Disorientation 2 2
Cardiopulmonary Arrest 2 2
Dyspnea 2 2
Overdose 2 2
Pneumothorax 2 2
Low Blood Pressure/ Hypotension 2 2
Unspecified Respiratory Problem 2 2
Cerebral Edema 2 2
Asystole 1 1
Cardiovascular Insufficiency 1 1
Unspecified Tissue Injury 1 1
Anemia 1 1
Failure of Implant 1 1
Seizures 1 1
Endocarditis 1 1
Hyperventilation 1 1
Bronchitis 1 1
Loss Of Pulse 1 1
Diminished Pulse Pressure 1 1
Burn, Thermal 1 1
Therapeutic Response, Decreased 1 1
Complaint, Ill-Defined 1 1
Fracture, Arm 1 1
Ventilator Dependent 1 1
Overinflation of Lung 1 1
Weakness 1 1
Obstruction/Occlusion 1 1
Pallor 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Carefusion 2200 Inc II Aug-13-2013
2 GE Healthcare II Feb-03-2014
3 GE Healthcare, LLC I Feb-25-2014
4 GE Healthcare, LLC I Feb-08-2013
5 Precision Medical, Inc. II May-09-2010
6 Sun Med, LLC II Jun-09-2018
7 SunMed Holdings, LLC II Nov-21-2023
8 Teleflex Medical I Jun-24-2015
9 Unomedical I Nov-04-2009
10 Ventlab Corporation I Nov-01-2012
11 Ventlab LLC I Jul-03-2014
12 Vyaire Medical I Feb-25-2024
13 Vyaire Medical I Aug-08-2018
14 Westmed Inc I Sep-08-2010
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