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TPLC
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show TPLC since
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2023
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Device
filter, bacterial, breathing-circuit
Product Code
CAH
Regulation Number
868.5260
Device Class
2
Premarket Reviews
Manufacturer
Decision
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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