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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device heater, breathing system w/wo controller (not humidifier or nebulizer
Product CodeBZE
Regulation Number 868.5270
Device Class 2


Premarket Reviews
ManufacturerDecision
DRAEGERWERK AG & CO. KGAA
  SUBSTANTIALLY EQUIVALENT 1
SUNSET HEALTHCARE SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 134 134
2020 123 123
2021 124 124
2022 152 152
2023 123 123
2024 51 51

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 274 274
Gas/Air Leak 149 149
Crack 81 81
Disconnection 57 57
Break 53 53
Insufficient Heating 53 53
Therapeutic or Diagnostic Output Failure 42 42
Material Split, Cut or Torn 38 38
Failure of Device to Self-Test 29 29
Incorrect, Inadequate or Imprecise Result or Readings 19 19
Connection Problem 16 16
Loose or Intermittent Connection 15 15
Fluid/Blood Leak 14 14
Detachment of Device or Device Component 14 14
Material Puncture/Hole 13 13
Degraded 11 11
Melted 9 9
Material Separation 7 7
No Apparent Adverse Event 7 7
Manufacturing, Packaging or Shipping Problem 6 6
Material Deformation 6 6
Use of Device Problem 6 6
Ambient Temperature Problem 5 5
Device Handling Problem 5 5
Output Problem 4 4
Infusion or Flow Problem 4 4
Component Missing 4 4
Misconnection 4 4
Improper or Incorrect Procedure or Method 3 3
Fire 3 3
Corroded 3 3
Fitting Problem 3 3
Failure to Disconnect 3 3
Moisture or Humidity Problem 3 3
Device Fell 3 3
Adverse Event Without Identified Device or Use Problem 2 2
Pressure Problem 2 2
Protective Measures Problem 2 2
Material Perforation 2 2
Material Twisted/Bent 2 2
Device Alarm System 2 2
Thermal Decomposition of Device 2 2
Material Discolored 2 2
Misassembled 2 2
Overfill 2 2
Obstruction of Flow 2 2
Appropriate Term/Code Not Available 2 2
Misassembled During Installation 2 2
Dent in Material 1 1
Insufficient Flow or Under Infusion 1 1
Product Quality Problem 1 1
Overheating of Device 1 1
Decrease in Pressure 1 1
Increase in Pressure 1 1
Inadequacy of Device Shape and/or Size 1 1
Device Slipped 1 1
Fracture 1 1
Material Disintegration 1 1
Complete Blockage 1 1
Mechanics Altered 1 1
Material Integrity Problem 1 1
Installation-Related Problem 1 1
Human-Device Interface Problem 1 1
Device Displays Incorrect Message 1 1
Sparking 1 1
Deformation Due to Compressive Stress 1 1
Contamination /Decontamination Problem 1 1
Insufficient Information 1 1
Unintended Movement 1 1
Misassembly by Users 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 459 459
No Patient Involvement 113 113
No Known Impact Or Consequence To Patient 67 67
No Consequences Or Impact To Patient 36 36
Low Oxygen Saturation 27 27
Insufficient Information 7 7
Bradycardia 4 4
Burn(s) 2 2
Hypoventilation 2 2
Hypoxia 2 2
Burning Sensation 2 2
Aspiration/Inhalation 1 1
Irritability 1 1
Increased Peak Expiratory Flow rate 1 1
Full thickness (Third Degree) Burn 1 1
Unspecified Respiratory Problem 1 1
Laceration(s) 1 1
Pneumothorax 1 1
Death 1 1
Dyspnea 1 1
Respiratory Failure 1 1
Increased Respiratory Rate 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Teleflex Medical I Jul-15-2019
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