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TPLC
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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
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
89
89
Device Problems
MDRs with this Device Problem
Events in those MDRs
Leak/Splash
235
235
Gas/Air Leak
145
145
Crack
87
87
Insufficient Heating
72
72
Disconnection
63
63
Break
52
52
Therapeutic or Diagnostic Output Failure
42
42
Material Split, Cut or Torn
34
34
Failure of Device to Self-Test
29
29
Connection Problem
24
24
Incorrect, Inadequate or Imprecise Result or Readings
19
19
Material Puncture/Hole
15
15
Detachment of Device or Device Component
15
15
Temperature Problem
14
14
Loose or Intermittent Connection
14
14
Moisture or Humidity Problem
11
11
Use of Device Problem
10
10
Melted
9
9
Degraded
8
8
No Apparent Adverse Event
8
8
Material Separation
7
7
Manufacturing, Packaging or Shipping Problem
6
6
Ambient Temperature Problem
6
6
Device Handling Problem
6
6
Material Perforation
5
5
Misconnection
4
4
Fluid/Blood Leak
4
4
Device Displays Incorrect Message
4
4
Infusion or Flow Problem
4
4
Material Deformation
4
4
Output Problem
4
4
Adverse Event Without Identified Device or Use Problem
3
3
Obstruction of Flow
3
3
Fitting Problem
3
3
Failure to Disconnect
3
3
Fire
3
3
Thermal Decomposition of Device
3
3
Component Missing
3
3
Improper or Incorrect Procedure or Method
3
3
Device Fell
3
3
Misassembled During Installation
2
2
Device Issue
2
2
Overheating of Device
2
2
Misassembled
2
2
Air Leak
2
2
Device Alarm System
2
2
Material Discolored
2
2
Detachment Of Device Component
2
2
Fracture
2
2
Material Twisted/Bent
2
2
Insufficient Information
2
2
Appropriate Term/Code Not Available
2
2
Pressure Problem
2
2
Protective Measures Problem
2
2
Unintended Movement
1
1
Misassembly by Users
1
1
Mechanical Jam
1
1
Mechanics Altered
1
1
Material Integrity Problem
1
1
Power Problem
1
1
Dent in Material
1
1
Sparking
1
1
Deformation Due to Compressive Stress
1
1
Contamination /Decontamination Problem
1
1
Installation-Related Problem
1
1
Human-Device Interface Problem
1
1
Improper Flow or Infusion
1
1
Device Operates Differently Than Expected
1
1
Device-Device Incompatibility
1
1
Material Disintegration
1
1
Mechanical Problem
1
1
Component Falling
1
1
Complete Blockage
1
1
Decrease in Pressure
1
1
Inadequacy of Device Shape and/or Size
1
1
Device Slipped
1
1
Device Inoperable
1
1
Overfill
1
1
Defective Component
1
1
Insufficient Flow or Under Infusion
1
1
Product Quality Problem
1
1
Intermittent Loss of Power
1
1
Unexpected Shutdown
1
1
Separation Problem
1
1
Noise, Audible
1
1
Patient Device Interaction Problem
1
1
Component Misassembled
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
375
375
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
28
28
Insufficient Information
6
6
Bradycardia
4
4
Hypoxia
3
3
Hypoventilation
2
2
Burn(s)
2
2
Burning Sensation
2
2
Cardiac Arrest
1
1
Death
1
1
Dyspnea
1
1
Aspiration/Inhalation
1
1
Laceration(s)
1
1
Pneumothorax
1
1
Respiratory Failure
1
1
Increased Respiratory Rate
1
1
Irritability
1
1
Increased Peak Expiratory Flow rate
1
1
Full thickness (Third Degree) Burn
1
1
No Code Available
1
1
Unspecified Respiratory Problem
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Teleflex Medical
I
Jul-15-2019
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