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TPLC
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Device
heater, breathing system w/wo controller (not humidifier or nebulizer
Regulation Description
Breathing system heater.
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
MEDLINE INDUSTRIES, LP
SUBSTANTIALLY EQUIVALENT
1
SUNSET HEALTHCARE SOLUTIONS, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
123
123
2021
124
124
2022
152
152
2023
124
124
2024
177
177
2025
11
11
Device Problems
MDRs with this Device Problem
Events in those MDRs
Leak/Splash
281
281
Gas/Air Leak
205
205
Crack
83
83
Break
52
52
Material Split, Cut or Torn
40
40
Therapeutic or Diagnostic Output Failure
40
40
Insufficient Heating
30
30
Failure of Device to Self-Test
28
28
Disconnection
28
28
Fluid/Blood Leak
27
27
Connection Problem
14
14
Incorrect, Inadequate or Imprecise Result or Readings
12
12
Loose or Intermittent Connection
12
12
Degraded
11
11
Material Puncture/Hole
10
10
Detachment of Device or Device Component
9
9
Mechanical Problem
9
9
Use of Device Problem
6
6
Misconnection
5
5
Manufacturing, Packaging or Shipping Problem
5
5
Component Missing
5
5
Infusion or Flow Problem
4
4
Moisture or Humidity Problem
4
4
Material Deformation
4
4
Melted
4
4
Fracture
3
3
Misassembled
3
3
Improper or Incorrect Procedure or Method
3
3
Output Problem
3
3
Fitting Problem
3
3
Failure to Disconnect
3
3
Corroded
3
3
Overfill
2
2
Fire
2
2
Appropriate Term/Code Not Available
2
2
Ambient Temperature Problem
2
2
Material Perforation
2
2
Material Twisted/Bent
2
2
Obstruction of Flow
2
2
Misassembled During Installation
2
2
Insufficient Information
2
2
Misassembly by Users
2
2
Protective Measures Problem
2
2
Contamination /Decontamination Problem
1
1
Decrease in Pressure
1
1
Noise, Audible
1
1
Complete Blockage
1
1
Thermal Decomposition of Device
1
1
Material Discolored
1
1
Deformation Due to Compressive Stress
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
589
589
No Patient Involvement
50
50
No Known Impact Or Consequence To Patient
28
28
Low Oxygen Saturation
20
20
No Consequences Or Impact To Patient
11
11
Insufficient Information
9
9
Hypoxia
3
3
Burning Sensation
3
3
Aspiration/Inhalation
3
3
Dizziness
2
2
Bradycardia
2
2
Headache
2
2
Respiratory Failure
1
1
Unspecified Vascular Problem
1
1
Irritability
1
1
Laceration(s)
1
1
Dyspnea
1
1
Unspecified Respiratory Problem
1
1
Abnormal Blood Gases
1
1
Pneumothorax
1
1
Hypoventilation
1
1
Tachycardia
1
1
Increased Peak Expiratory Flow rate
1
1
Respiratory Arrest
1
1
Increased Respiratory Rate
1
1
Death
1
1
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