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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
1. K151303
AirLife Infant Heated Wire Circuit
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
SUNSET HEALTHCARE SOLUTIONS, INC.
SUBSTANTIALLY EQUIVALENT
1
TELEFLEX MEDICAL, INC
SUBSTANTIALLY EQUIVALENT
1
VYAIRE MEDICAL
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
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
368
368
Crack
319
319
Gas/Air Leak
177
177
Insufficient Heating
141
141
Disconnection
97
97
Temperature Problem
90
90
Break
88
88
Therapeutic or Diagnostic Output Failure
42
42
Connection Problem
41
41
Material Split, Cut or Torn
40
40
Moisture or Humidity Problem
35
35
Device Issue
34
34
Failure of Device to Self-Test
32
32
Loose or Intermittent Connection
31
31
Melted
23
23
Incorrect, Inadequate or Imprecise Result or Readings
21
21
Device Operates Differently Than Expected
20
20
Fluid/Blood Leak
17
17
Detachment of Device or Device Component
17
17
Material Puncture/Hole
15
15
Hole In Material
15
15
Detachment Of Device Component
14
14
Air Leak
14
14
Degraded
13
13
Use of Device Problem
11
11
Material Separation
10
10
Cut In Material
9
9
Device Displays Incorrect Message
9
9
Device Handling Problem
9
9
Adverse Event Without Identified Device or Use Problem
8
8
No Apparent Adverse Event
8
8
Material Deformation
6
6
Mechanical Problem
6
6
Ambient Temperature Problem
6
6
Manufacturing, Packaging or Shipping Problem
6
6
Material Perforation
6
6
Insufficient Information
6
6
Failure to Power Up
6
6
Fitting Problem
6
6
Split
5
5
Power Problem
5
5
Overheating of Device
5
5
Material Integrity Problem
5
5
Component Missing
5
5
Device Slipped
5
5
Output Problem
4
4
Misconnection
4
4
Infusion or Flow Problem
4
4
Thermal Decomposition of Device
4
4
Pressure Problem
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
305
305
No Patient Involvement
305
305
No Consequences Or Impact To Patient
266
266
Low Oxygen Saturation
49
49
No Information
11
11
Insufficient Information
7
7
Bradycardia
7
7
No Code Available
5
5
Tachycardia
4
4
Aspiration/Inhalation
3
3
Cardiac Arrest
3
3
Burning Sensation
3
3
Hypoxia
3
3
Patient Problem/Medical Problem
2
2
Hypoventilation
2
2
Dizziness
2
2
Burn(s)
2
2
Increased Respiratory Rate
2
2
Headache
2
2
Death
1
1
Pneumothorax
1
1
Respiratory Distress
1
1
Respiratory Arrest
1
1
Fever
1
1
Needle Stick/Puncture
1
1
Exposure to Body Fluids
1
1
Dyspnea
1
1
Laceration(s)
1
1
Fluid Discharge
1
1
Pulmonary Edema
1
1
Unspecified Respiratory Problem
1
1
Extubate
1
1
Irritability
1
1
Unspecified Vascular Problem
1
1
Full thickness (Third Degree) Burn
1
1
Respiratory Failure
1
1
Increased Peak Expiratory Flow rate
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Teleflex Medical
I
Jul-15-2019
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