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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 1
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
NDD MEDIZINTECHNIK AG
  SUBSTANTIALLY EQUIVALENT 1
NINGBO HUAKUN MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PALL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
PHARMA SYSTEM AB
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 33 33
2019 30 30
2020 32 32
2021 56 56
2022 67 67
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Obstruction of Flow 26 26
Gas/Air Leak 18 18
Material Split, Cut or Torn 15 15
Break 14 14
Material Separation 13 13
Detachment of Device or Device Component 12 12
Filtration Problem 11 11
Pressure Problem 11 11
Leak/Splash 11 11
Partial Blockage 10 10
Crack 8 8
Infusion or Flow Problem 8 8
Device Markings/Labelling Problem 7 7
Complete Blockage 7 7
Device Damaged Prior to Use 5 5
Contamination 4 4
Improper Flow or Infusion 4 4
Output Problem 4 4
Moisture or Humidity Problem 3 3
Device Contamination with Chemical or Other Material 3 3
Connection Problem 3 3
Failure to Deliver 3 3
Occlusion Within Device 3 3
Device Alarm System 3 3
Disconnection 3 3
Loose or Intermittent Connection 3 3
Mechanical Problem 3 3
Fracture 2 2
Material Fragmentation 2 2
Gas Output Problem 2 2
Excess Flow or Over-Infusion 2 2
Defective Component 2 2
Component Missing 2 2
Material Deformation 2 2
Defective Device 2 2
No Flow 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Contamination /Decontamination Problem 2 2
Appropriate Term/Code Not Available 2 2
Sharp Edges 1 1
Air/Gas in Device 1 1
Insufficient Information 1 1
Temperature Problem 1 1
Packaging Problem 1 1
Device Displays Incorrect Message 1 1
Split 1 1
Device Operates Differently Than Expected 1 1
Device Damaged by Another Device 1 1
Device Dislodged or Dislocated 1 1
Environmental Compatibility Problem 1 1
Environmental Particulates 1 1
Material Integrity Problem 1 1
Contamination of Device Ingredient or Reagent 1 1
Free or Unrestricted Flow 1 1
Inadequate Filtration Process 1 1
Inaccurate Delivery 1 1
Tear, Rip or Hole in Device Packaging 1 1
Failure to Run on Battery 1 1
Decrease in Pressure 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Device Slipped 1 1
Tidal Volume Fluctuations 1 1
Use of Device Problem 1 1
Misassembled 1 1
Moisture Damage 1 1
Material Disintegration 1 1
Fluid/Blood Leak 1 1
Air Leak 1 1
Collapse 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 74 74
No Consequences Or Impact To Patient 44 44
Low Oxygen Saturation 32 32
Insufficient Information 17 17
No Patient Involvement 16 16
No Known Impact Or Consequence To Patient 12 12
No Information 6 6
Bradycardia 6 6
Respiratory Distress 4 4
Sepsis 3 3
Urinary Tract Infection 3 3
Pulmonary Emphysema 3 3
Pneumothorax 3 3
Unspecified Respiratory Problem 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
No Code Available 2 2
Respiratory Failure 2 2
Cyanosis 2 2
Discomfort 2 2
Ventilator Dependent 1 1
Extubate 1 1
Distress 1 1
Electrolyte Imbalance 1 1
Airway Obstruction 1 1
Cardiopulmonary Arrest 1 1
Low Blood Pressure/ Hypotension 1 1
Hypoventilation 1 1
Hypoxia 1 1
Decreased Respiratory Rate 1 1
Patient Problem/Medical Problem 1 1
Cough 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 TELEFLEX LLC I Oct-14-2022
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