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TPLC
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show TPLC since
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Device
heater, breathing system w/wo controller (not humidifier or nebulizer
Product Code
BZE
Regulation Number
868.5270
Device Class
2
Premarket Reviews
Manufacturer
Decision
CAREFUSION
SUBSTANTIALLY EQUIVALENT
1
CAREFUSION INC
SUBSTANTIALLY EQUIVALENT
2
DRAEGERWERK AG & CO. KGAA
SUBSTANTIALLY EQUIVALENT
1
EXCELERON MEDICAL
SUBSTANTIALLY EQUIVALENT
1
FLEXICARE MEDICAL LIMITED
SUBSTANTIALLY EQUIVALENT
1
FLEXICARE MEDICAL LTD.
SUBSTANTIALLY EQUIVALENT
1
MEDLINE INDUSTRIES, LP
SUBSTANTIALLY EQUIVALENT
1
PLASTIFLEX GROUP NV
SUBSTANTIALLY EQUIVALENT
1
RESPIRONICS, INC.
SUBSTANTIALLY EQUIVALENT
1
SUNSET HEALTHCARE SOLUTIONS, INC.
SUBSTANTIALLY EQUIVALENT
1
TELEFLEX MEDICAL, INC
SUBSTANTIALLY EQUIVALENT
1
VYAIRE MEDICAL
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
338
338
2015
155
155
2016
212
212
2017
209
209
2018
103
103
2019
134
134
2020
123
123
2021
124
124
2022
152
152
2023
124
124
2024
103
103
Device Problems
MDRs with this Device Problem
Events in those MDRs
Leak/Splash
418
418
Crack
358
358
Gas/Air Leak
177
177
Insufficient Heating
159
159
Break
133
133
Disconnection
114
114
Temperature Problem
94
94
Device Operates Differently Than Expected
84
84
Failure of Device to Self-Test
51
51
Hole In Material
49
49
Connection Problem
44
44
Therapeutic or Diagnostic Output Failure
42
42
Moisture or Humidity Problem
41
41
Material Split, Cut or Torn
40
40
Device Issue
34
34
Melted
31
31
Loose or Intermittent Connection
31
31
Device Displays Incorrect Message
28
28
Air Leak
23
23
Fluid/Blood Leak
22
22
Incorrect, Inadequate or Imprecise Result or Readings
21
21
Detachment of Device or Device Component
17
17
Detachment Of Device Component
17
17
Material Puncture/Hole
15
15
Power Problem
13
13
Device Damaged Prior to Use
13
13
Degraded
13
13
Material Separation
12
12
Use of Device Problem
11
11
Failure to Power Up
11
11
Adverse Event Without Identified Device or Use Problem
10
10
Device Slipped
10
10
Device Handling Problem
9
9
Cut In Material
9
9
No Apparent Adverse Event
8
8
Overheating of Device
8
8
Insufficient Information
7
7
Material Perforation
6
6
Material Deformation
6
6
Material Integrity Problem
6
6
Mechanical Problem
6
6
Ambient Temperature Problem
6
6
Manufacturing, Packaging or Shipping Problem
6
6
Pressure Problem
6
6
Fitting Problem
6
6
Split
5
5
Decrease in Pressure
5
5
Component Missing
5
5
Improper or Incorrect Procedure or Method
4
4
Thermal Decomposition of Device
4
4
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
509
509
No Known Impact Or Consequence To Patient
462
462
No Patient Involvement
428
428
No Consequences Or Impact To Patient
291
291
Low Oxygen Saturation
53
53
No Information
30
30
No Code Available
8
8
Insufficient Information
7
7
Bradycardia
7
7
Tachycardia
6
6
Aspiration/Inhalation
4
4
Cardiac Arrest
3
3
Burning Sensation
3
3
Hypoxia
3
3
Increased Respiratory Rate
3
3
Patient Problem/Medical Problem
2
2
Hypoventilation
2
2
Full thickness (Third Degree) Burn
2
2
Respiratory Distress
2
2
Dizziness
2
2
Headache
2
2
Injury
2
2
Burn(s)
2
2
Increased Peak Expiratory Flow rate
1
1
Respiratory Failure
1
1
Unspecified Vascular Problem
1
1
Irritability
1
1
Extubate
1
1
Unspecified Respiratory Problem
1
1
Therapeutic Response, Decreased
1
1
Partial thickness (Second Degree) Burn
1
1
Pulmonary Edema
1
1
Fluid Discharge
1
1
Laceration(s)
1
1
Dyspnea
1
1
Scar Tissue
1
1
Exposure to Body Fluids
1
1
Needle Stick/Puncture
1
1
Fever
1
1
Alteration In Body Temperature
1
1
Respiratory Arrest
1
1
Pneumothorax
1
1
Death
1
1
High Blood Pressure/ Hypertension
1
1
Unspecified Infection
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Carefusion 2200 Inc
II
Sep-23-2014
2
Teleflex Medical
I
Jul-15-2019
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