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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device filter, bacterial, breathing-circuit
Product CodeCAH
Regulation Number 868.5260
Device Class 2


Premarket Reviews
ManufacturerDecision
FLEXICARE MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 2
GREAT GROUP MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MAQUET CRITICAL CARE AB
  SUBSTANTIALLY EQUIVALENT 1
MD DIAGNOSTICS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
MEDITERA TIBBI MALZEME SAN. VE TIC. A.S.
  SUBSTANTIALLY EQUIVALENT 1
PALL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
PHARMA SYSTEM AB
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 28 28
2018 33 33
2019 30 30
2020 31 31
2021 56 56
2022 19 19

Device Problems MDRs with this Device Problem Events in those MDRs
Obstruction of Flow 23 23
Gas Leak 17 17
Partial Blockage 14 14
Material Separation 13 13
Material Split, Cut or Torn 12 12
Filtration Problem 11 11
Detachment of Device or Device Component 11 11
Break 10 10
Pressure Problem 10 10
Infusion or Flow Problem 9 9
Leak/Splash 9 9
Crack 8 8
Complete Blockage 7 7
Occlusion Within Device 6 6
Device Contamination with Chemical or Other Material 6 6
Moisture or Humidity Problem 4 4
Output Problem 4 4
Disconnection 4 4
Loose or Intermittent Connection 3 3
Device Operates Differently Than Expected 3 3
Connection Problem 3 3
Improper Flow or Infusion 3 3
Material Deformation 2 2
Excess Flow or Over-Infusion 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Appropriate Term/Code Not Available 2 2
Device Displays Incorrect Message 2 2
Device Damaged Prior to Use 2 2
Defective Component 2 2
Failure to Deliver 2 2
Inaccurate Delivery 2 2
Mechanical Problem 2 2
Air Leak 2 2
Device Alarm System 2 2
Contamination 2 2
Material Disintegration 1 1
Fluid Leak 1 1
Fracture 1 1
Material Fragmentation 1 1
Gas Output Problem 1 1
Incorrect, Inadequate or Imprecise Resultor Readings 1 1
Misassembled 1 1
Moisture Damage 1 1
Device Slipped 1 1
Use of Device Problem 1 1
Split 1 1
Defective Device 1 1
Blocked Connection 1 1
Contamination /Decontamination Problem 1 1
Contamination of Device Ingredient or Reagent 1 1
Device Damaged by Another Device 1 1
Environmental Compatibility Problem 1 1
Packaging Problem 1 1
Temperature Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Sharp Edges 1 1
Material Integrity Problem 1 1
No Flow 1 1
Free or Unrestricted Flow 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 55 55
Low Oxygen Saturation 31 31
No Clinical Signs, Symptoms or Conditions 30 30
No Patient Involvement 17 17
No Known Impact Or Consequence To Patient 16 16
Insufficient Information 15 15
Respiratory Distress 8 8
Bradycardia 7 7
No Information 6 6
Pneumothorax 3 3
Pulmonary Emphysema 3 3
Sepsis 3 3
Urinary Tract Infection 3 3
Discomfort 2 2
Cyanosis 2 2
Respiratory Failure 2 2
Decreased Respiratory Rate 2 2
No Code Available 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Unspecified Respiratory Problem 1 1
Not Applicable 1 1
Loss Of Pulse 1 1
Bronchospasm 1 1
Airway Obstruction 1 1
Patient Problem/Medical Problem 1 1
Death 1 1
Cardiac Arrest 1 1
Cardiopulmonary Arrest 1 1
Low Blood Pressure/ Hypotension 1 1
Hypoventilation 1 1
Hypoxia 1 1
Ventilator Dependent 1 1
Extubate 1 1
Electrolyte Imbalance 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Alliance Tech Medical, Inc II Dec-19-2019
2 Covidien, LP II Jun-16-2021
3 King Systems Corp. dba Ambu, Inc. II Jan-05-2018
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