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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device mixer, breathing gases, anesthesia inhalation
Regulation Description Breathing gas mixer.
Product CodeBZR
Regulation Number 868.5330
Device Class 2


Premarket Reviews
ManufacturerDecision
BALDUS SEDATION GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 2
DEHAS MEDICAL SYSTEMS GMBH
  SUBSTANTIALLY EQUIVALENT 1
FISHER &PAYKEL HEALTHCARE , LTD.
  SUBSTANTIALLY EQUIVALENT 1
MAXTEC, LLC
  SUBSTANTIALLY EQUIVALENT 1
PARKER HANNIFIN
  SUBSTANTIALLY EQUIVALENT 1
  1.  K202480  Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 5 ...
PARKER HANNIFIN CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 15 15
2021 33 34
2022 15 15
2023 19 19
2024 18 18
2025 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 34 34
Leak/Splash 8 8
No Audible Alarm 5 5
Output Problem 4 4
Device Contamination with Body Fluid 4 4
Gas Output Problem 4 4
Device Alarm System 3 3
Fire 3 3
Insufficient Information 3 3
Component Misassembled 3 3
Therapeutic or Diagnostic Output Failure 3 3
Protective Measures Problem 2 2
Contamination 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Misassembled 2 2
Inaccurate Delivery 2 2
Gas/Air Leak 2 2
Defective Device 2 2
No Flow 2 2
Appropriate Term/Code Not Available 2 2
Pressure Problem 1 1
Material Integrity Problem 1 1
Positioning Problem 1 1
Material Frayed 1 1
Device Damaged by Another Device 1 1
Infusion or Flow Problem 1 1
Failure to Align 1 1
Failure to Deliver 1 1
Device Handling Problem 1 1
Improper or Incorrect Procedure or Method 1 1
No Audible Prompt/Feedback 1 1
High Readings 1 1
Display or Visual Feedback Problem 1 1
Medical Gas Supply Problem 1 1
Volume Accuracy Problem 1 1
Melted 1 1
Crack 1 1
Output above Specifications 1 1
Improper Flow or Infusion 1 2
No Apparent Adverse Event 1 1
No Display/Image 1 1
Activation, Positioning or Separation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 80 81
Low Oxygen Saturation 14 14
Insufficient Information 10 10
No Information 3 3
No Patient Involvement 2 2
No Consequences Or Impact To Patient 2 2
Hypoxia 1 1
Respiratory Arrest 1 1
Superficial (First Degree) Burn 1 1

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