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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
DRAEGERWERK AG & CO. KGAA
SUBSTANTIALLY EQUIVALENT
1
EXCELERON MEDICAL
SUBSTANTIALLY EQUIVALENT
1
1. K241268
Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH
...
MEDLINE INDUSTRIES, LP
SUBSTANTIALLY EQUIVALENT
1
SUNSET HEALTHCARE SOLUTIONS, INC.
SUBSTANTIALLY EQUIVALENT
1
TELEFLEX MEDICAL, INC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
103
103
2019
134
134
2020
123
123
2021
124
124
2022
152
152
2023
125
125
2024
121
121
Device Problems
MDRs with this Device Problem
Events in those MDRs
Leak/Splash
312
312
Gas/Air Leak
184
184
Crack
105
105
Insufficient Heating
72
72
Disconnection
65
65
Break
56
56
Therapeutic or Diagnostic Output Failure
42
42
Material Split, Cut or Torn
41
41
Failure of Device to Self-Test
29
29
Connection Problem
25
25
Fluid/Blood Leak
20
20
Incorrect, Inadequate or Imprecise Result or Readings
19
19
Loose or Intermittent Connection
17
17
Material Puncture/Hole
15
15
Detachment of Device or Device Component
15
15
Temperature Problem
14
14
Degraded
13
13
Moisture or Humidity Problem
11
11
Melted
11
11
Use of Device Problem
10
10
No Apparent Adverse Event
8
8
Material Separation
7
7
Device Handling Problem
6
6
Mechanical Problem
6
6
Ambient Temperature Problem
6
6
Manufacturing, Packaging or Shipping Problem
6
6
Misconnection
5
5
Material Deformation
5
5
Material Perforation
5
5
Component Missing
5
5
Infusion or Flow Problem
4
4
Fracture
4
4
Output Problem
4
4
Device Displays Incorrect Message
4
4
Device Fell
3
3
Insufficient Information
3
3
Obstruction of Flow
3
3
Corroded
3
3
Improper or Incorrect Procedure or Method
3
3
Fire
3
3
Thermal Decomposition of Device
3
3
Failure to Disconnect
3
3
Misassembled
3
3
Fitting Problem
3
3
Adverse Event Without Identified Device or Use Problem
3
3
Protective Measures Problem
2
2
Appropriate Term/Code Not Available
2
2
Overheating of Device
2
2
Device Issue
2
2
Detachment Of Device Component
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
528
528
No Patient Involvement
146
146
No Known Impact Or Consequence To Patient
96
96
No Consequences Or Impact To Patient
77
77
Low Oxygen Saturation
27
27
Insufficient Information
8
8
Bradycardia
4
4
Aspiration/Inhalation
3
3
Burning Sensation
3
3
Hypoxia
3
3
Hypoventilation
2
2
Dizziness
2
2
Burn(s)
2
2
Headache
2
2
Death
1
1
Pneumothorax
1
1
No Code Available
1
1
Respiratory Arrest
1
1
Cardiac Arrest
1
1
Dyspnea
1
1
Laceration(s)
1
1
Tachycardia
1
1
Increased Respiratory Rate
1
1
Unspecified Respiratory Problem
1
1
Irritability
1
1
Unspecified Vascular Problem
1
1
Respiratory Failure
1
1
Full thickness (Third Degree) Burn
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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