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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
DRÄGERWERK AG & CO. KGAA
  SUBSTANTIALLY EQUIVALENT 1
FLEXICARE MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 2
GREAT GROUP MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INTERSURGICAL 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
NDD MEDIZINTECHNIK AG
  SUBSTANTIALLY EQUIVALENT 1
NINGBO HUAKUN MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PALL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
PASSY-MUIR, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHARMA SYSTEM AB
  SUBSTANTIALLY EQUIVALENT 1
SHAOXING HAITECH MEDICAL PRODUCTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 34 34
2017 28 28
2018 33 33
2019 30 30
2020 32 32
2021 56 56
2022 67 67
2023 40 40
2024 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
Obstruction of Flow 33 33
Gas/Air Leak 23 23
Material Separation 20 20
Leak/Splash 19 19
Break 17 17
Partial Blockage 16 16
Crack 16 16
Material Split, Cut or Torn 16 16
Disconnection 13 13
Pressure Problem 13 13
Detachment of Device or Device Component 12 12
Filtration Problem 11 11
Complete Blockage 10 10
Mechanical Problem 10 10
Use of Device Problem 10 10
Infusion or Flow Problem 9 9
Moisture or Humidity Problem 8 8
Device Contamination with Chemical or Other Material 7 7
Device Markings/Labelling Problem 7 7
Device Operates Differently Than Expected 7 7
Air Leak 7 7
Device Damaged Prior to Use 6 6
Occlusion Within Device 6 6
Improper Flow or Infusion 6 6
Device Displays Incorrect Message 5 5
Output Problem 4 4
Component Missing 4 4
Contamination 4 4
Insufficient Information 4 4
Appropriate Term/Code Not Available 3 3
Fracture 3 3
Device Alarm System 3 3
Defective Component 3 3
Sticking 3 3
Particulates 3 3
Loose or Intermittent Connection 3 3
No Flow 3 3
Contamination /Decontamination Problem 3 3
Connection Problem 3 3
Failure to Deliver 3 3
Inaccurate Delivery 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Material Deformation 2 2
Inadequate Filtration Process 2 2
Detachment Of Device Component 2 2
Material Fragmentation 2 2
Gas Output Problem 2 2
Fluid/Blood Leak 2 2
Excess Flow or Over-Infusion 2 2
Therapeutic or Diagnostic Output Failure 2 2
Defective Device 2 2
Sharp Edges 1 1
Air/Gas in Device 1 1
Misassembly by Users 1 1
Difficult to Insert 1 1
Imprecision 1 1
Material Disintegration 1 1
Collapse 1 1
Device Contamination with Body Fluid 1 1
Tidal Volume Fluctuations 1 1
Device Inoperable 1 1
Device Slipped 1 1
Misassembled 1 1
Moisture Damage 1 1
Failure to Run on Battery 1 1
Decrease in Pressure 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Material Integrity Problem 1 1
Packaging Problem 1 1
Temperature Problem 1 1
Contamination of Device Ingredient or Reagent 1 1
Blocked Connection 1 1
Free or Unrestricted Flow 1 1
Device Issue 1 1
Tear, Rip or Hole in Device Packaging 1 1
Structural Problem 1 1
Decreased Sensitivity 1 1
Split 1 1
Device Damaged by Another Device 1 1
Device Dislodged or Dislocated 1 1
Environmental Compatibility Problem 1 1
Environmental Particulates 1 1
Failure of Device to Self-Test 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 103 103
No Consequences Or Impact To Patient 65 65
Low Oxygen Saturation 42 42
No Known Impact Or Consequence To Patient 29 29
Insufficient Information 23 23
No Patient Involvement 21 21
Bradycardia 10 10
No Information 10 10
Respiratory Distress 9 9
Respiratory Failure 4 4
Cardiac Arrest 4 4
Cyanosis 3 3
Pulmonary Emphysema 3 3
Hypoventilation 3 3
Hypoxia 3 3
Pneumothorax 3 3
Diminished Pulse Pressure 3 3
Sepsis 3 3
Urinary Tract Infection 3 3
No Code Available 3 3
Cough 3 3
Respiratory Arrest 3 3
Unspecified Respiratory Problem 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Discomfort 2 2
Ventilator Dependent 2 2
Bronchospasm 2 2
Patient Problem/Medical Problem 2 2
Decreased Respiratory Rate 2 2
Death 2 2
Cardiopulmonary Arrest 2 2
Dyspnea 1 1
Capsular Contracture 1 1
Airway Obstruction 1 1
Aspiration/Inhalation 1 1
Pulmonary Edema 1 1
Fainting 1 1
High Blood Pressure/ Hypertension 1 1
Low Blood Pressure/ Hypotension 1 1
Loss Of Pulse 1 1
Extubate 1 1
Distress 1 1
Electrolyte Imbalance 1 1
Not Applicable 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 Draeger Medical, Inc. I Jun-10-2022
4 King Systems Corp. dba Ambu, Inc. II Jan-05-2018
5 S & MOHR AMERICA, S.A. DE C.V. III Feb-22-2023
6 Smiths Medical ASD Inc. II Aug-28-2023
7 TELEFLEX LLC I Oct-14-2022
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