• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device ventilator, emergency, manual (resuscitator)
Product CodeBTM
Regulation Number 868.5915
Device Class 2


Premarket Reviews
ManufacturerDecision
FLEXICARE MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
FOREMOUNT ENTERPRISE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
XIAMEN COMPOWER MEDICAL TECH. CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 56 56
2018 53 53
2019 46 46
2020 26 26
2021 42 42
2022 18 18

Device Problems MDRs with this Device Problem Events in those MDRs
Break 19 19
Inflation Problem 16 16
Device Damaged Prior to Use 13 13
Defective Device 13 13
Component Missing 12 12
Device Operates Differently Than Expected 12 12
Defective Component 12 12
Appropriate Term/Code Not Available 12 12
Connection Problem 11 11
Device Issue 9 9
Device Operational Issue 9 9
Fitting Problem 8 8
Material Deformation 7 7
Device Dislodged or Dislocated 6 6
Gas Leak 6 6
Detachment of Device or Device Component 6 6
Inadequacy of Device Shape and/or Size 6 6
Deflation Problem 6 6
Missing Value Reason 6 6
Loose or Intermittent Connection 5 5
Mechanical Problem 5 5
No Flow 5 5
Disconnection 4 4
Collapse 4 4
Air Leak 4 4
Leak/Splash 4 4
Product Quality Problem 4 4
Therapeutic or Diagnostic Output Failure 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Unintended Deflation 4 4
Physical Resistance/Sticking 3 3
Insufficient Information 3 3
Difficult to Remove 3 3
Material Puncture/Hole 3 3
Material Separation 3 3
Use of Device Problem 3 3
Detachment Of Device Component 3 3
Difficult to Open or Close 3 3
Failure to Disconnect 3 3
Failure to Deliver 3 3
Structural Problem 2 2
Separation Failure 2 2
Packaging Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Material Integrity Problem 2 2
Material Twisted/Bent 2 2
Crack 2 2
Disassembly 2 2
Device Alarm System 2 2
Hole In Material 2 2
Nonstandard Device 2 2
No Device Output 1 1
Increase in Pressure 1 1
Material Too Rigid or Stiff 1 1
Improper or Incorrect Procedure or Method 1 1
Suction Problem 1 1
Invalid Sensing 1 1
Shipping Damage or Problem 1 1
Unexpected Therapeutic Results 1 1
Arcing at Paddles 1 1
Complete Blockage 1 1
Failure to Deliver Energy 1 1
Fire 1 1
Fluid Leak 1 1
Melted 1 1
Misconnection 1 1
Moisture Damage 1 1
Mechanical Jam 1 1
Improper Flow or Infusion 1 1
Incorrect Device Or Component Shipped 1 1
No Pressure 1 1
Optical Distortion 1 1
Pressure Problem 1 1
Patient-Device Incompatibility 1 1
Device Markings/Labelling Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Activation, Positioning or SeparationProblem 1 1
Expiration Date Error 1 1
Obstruction of Flow 1 1
Incomplete or Missing Packaging 1 1
Ventilation Problem in Device Environment 1 1
No Apparent Adverse Event 1 1
Patient Device Interaction Problem 1 1
Material Split, Cut or Torn 1 1
Incomplete or Inadequate Connection 1 1
Suction Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 96 96
No Consequences Or Impact To Patient 34 34
Missing Value Reason 31 31
Insufficient Information 21 21
No Clinical Signs, Symptoms or Conditions 19 19
No Patient Involvement 14 14
Low Oxygen Saturation 14 14
Cardiac Arrest 10 10
Death 9 9
No Code Available 9 9
Hypoxia 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Not Applicable 3 3
No Information 2 2
Cerebral Edema 2 2
Loss of consciousness 2 2
Respiratory Arrest 2 2
Low Blood Pressure/ Hypotension 2 2
Vomiting 2 2
Anemia 1 1
Hypoventilation 1 1
Decreased Respiratory Rate 1 1
Burn, Thermal 1 1
Fracture, Arm 1 1
Pneumothorax 1 1
Respiratory Distress 1 1
Seizures 1 1
Dyspnea 1 1
Endocarditis 1 1
Cardiopulmonary Arrest 1 1
Unspecified Tissue Injury 1 1
Asystole 1 1
Cardiovascular Insufficiency 1 1
Foreign Body In Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Sun Med, LLC II Jun-09-2018
2 Vyaire Medical I Aug-08-2018
-
-