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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
2026 2 2

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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 81 82
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
Superficial (First Degree) Burn 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Respiratory Arrest 1 1
Hypoxia 1 1

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