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TPLC
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show TPLC since
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Device
filter, bacterial, breathing-circuit
Product Code
CAH
Regulation Number
868.5260
Device Class
2
Premarket Reviews
Manufacturer
Decision
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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