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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
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
MAXTEC, LLC
  SUBSTANTIALLY EQUIVALENT 1
  1.  K231895  Maxtec MaxBlend2+p
PARKER HANNIFIN
  SUBSTANTIALLY EQUIVALENT 1
PARKER HANNIFIN CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

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

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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 71 71
Low Oxygen Saturation 12 12
Insufficient Information 8 8
No Information 3 3
No Patient Involvement 2 2
No Consequences Or Impact To Patient 2 2
Respiratory Arrest 1 1
Superficial (First Degree) Burn 1 1
Hypoxia 1 1

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