Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
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
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
2018
33
33
2019
30
30
2020
32
32
2021
56
56
2022
67
67
2023
40
40
2024
10
10
Device Problems
MDRs with this Device Problem
Events in those MDRs
Obstruction of Flow
33
33
Gas/Air Leak
23
23
Material Split, Cut or Torn
16
16
Break
14
14
Material Separation
13
13
Crack
12
12
Leak/Splash
12
12
Detachment of Device or Device Component
12
12
Filtration Problem
11
11
Pressure Problem
11
11
Partial Blockage
11
11
Disconnection
10
10
Mechanical Problem
10
10
Complete Blockage
8
8
Infusion or Flow Problem
8
8
Device Markings/Labelling Problem
7
7
Use of Device Problem
7
7
Device Damaged Prior to Use
6
6
Improper Flow or Infusion
6
6
Insufficient Information
4
4
Output Problem
4
4
Contamination
4
4
Device Alarm System
3
3
Loose or Intermittent Connection
3
3
Defective Component
3
3
Component Missing
3
3
Occlusion Within Device
3
3
Particulates
3
3
Moisture or Humidity Problem
3
3
No Flow
3
3
Appropriate Term/Code Not Available
3
3
Device Contamination with Chemical or Other Material
3
3
Contamination /Decontamination Problem
3
3
Connection Problem
3
3
Failure to Deliver
3
3
Defective Device
2
2
Material Deformation
2
2
Adverse Event Without Identified Device or Use Problem
2
2
Therapeutic or Diagnostic Output Failure
2
2
Excess Flow or Over-Infusion
2
2
Fluid/Blood Leak
2
2
Fracture
2
2
Material Fragmentation
2
2
Gas Output Problem
2
2
Imprecision
1
1
Difficult to Insert
1
1
Air Leak
1
1
Collapse
1
1
Material Disintegration
1
1
Failure to Run on Battery
1
1
Decrease in Pressure
1
1
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Misassembled
1
1
Moisture Damage
1
1
Device Slipped
1
1
Tidal Volume Fluctuations
1
1
Inadequate Filtration Process
1
1
Device Contamination with Body Fluid
1
1
Structural Problem
1
1
Decreased Sensitivity
1
1
Split
1
1
Sharp Edges
1
1
Air/Gas in Device
1
1
Packaging Problem
1
1
Temperature Problem
1
1
Material Integrity Problem
1
1
Contamination of Device Ingredient or Reagent
1
1
Free or Unrestricted Flow
1
1
Device Displays Incorrect Message
1
1
Inaccurate Delivery
1
1
Tear, Rip or Hole in Device Packaging
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
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
99
99
No Consequences Or Impact To Patient
44
44
Low Oxygen Saturation
36
36
Insufficient Information
23
23
No Patient Involvement
16
16
No Known Impact Or Consequence To Patient
12
12
Bradycardia
8
8
No Information
6
6
Respiratory Distress
4
4
Sepsis
3
3
Urinary Tract Infection
3
3
Hypoventilation
3
3
Hypoxia
3
3
Pneumothorax
3
3
Cardiac Arrest
3
3
Cyanosis
3
3
Pulmonary Emphysema
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
Cough
3
3
Respiratory Arrest
3
3
Unspecified Respiratory Problem
3
3
Diminished Pulse Pressure
3
3
Respiratory Failure
2
2
No Code Available
2
2
Discomfort
2
2
Ventilator Dependent
2
2
Extubate
1
1
Patient Problem/Medical Problem
1
1
Not Applicable
1
1
Decreased Respiratory Rate
1
1
Bronchospasm
1
1
High Blood Pressure/ Hypertension
1
1
Low Blood Pressure/ Hypotension
1
1
Distress
1
1
Dyspnea
1
1
Cardiopulmonary Arrest
1
1
Capsular Contracture
1
1
Airway Obstruction
1
1
Aspiration/Inhalation
1
1
Pulmonary Edema
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
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
-
-