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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
MAXTEC, LLC
  SUBSTANTIALLY EQUIVALENT 1
O-TWO MEDICAL TECHNOLOGIES INC.
  SUBSTANTIALLY EQUIVALENT 1
PARKER HANNIFIN
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 30 30
2017 22 22
2018 24 24
2019 26 26
2020 15 15
2021 22 22

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operates Differently Than Expected 25 25
Device Alarm System 16 16
Mechanical Problem 16 16
No Audible Alarm 10 10
Leak/Splash 8 8
Inaccurate Delivery 8 8
Infusion or Flow Problem 6 6
Output Problem 5 5
Fire 5 5
Improper Device Output 4 4
Material Integrity Problem 4 4
No Apparent Adverse Event 4 4
Protective Measures Problem 3 3
Therapeutic or Diagnostic Output Failure 3 3
No Flow 3 3
Calibration Problem 3 3
Loose or Intermittent Connection 3 3
Excess Flow or Over-Infusion 2 2
Failure to Calibrate 2 2
Delayed Alarm 2 2
Defective Device 2 2
Improper Flow or Infusion 2 2
Contamination 2 2
Gas Leak 2 2
Positioning Problem 1 1
Programming Issue 1 1
Material Twisted/Bent 1 1
Medical Gas Supply Problem 1 1
Naturally Worn 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Misassembly During Maintenance/Repair 1 1
Crack 1 1
Material Frayed 1 1
Gas Output Problem 1 1
Break 1 1
False Alarm 1 1
Melted 1 1
Misconnection 1 1
Output above Specifications 1 1
No Device Output 1 1
Incorrect, Inadequate or Imprecise Resultor Readings 1 1
Device Slipped 1 1
Failure to Deliver 1 1
Free or Unrestricted Flow 1 1
Device Displays Incorrect Message 1 1
Incorrect Or Inadequate Test Results 1 1
High Readings 1 1
Kinked 1 1
Incorrect Measurement 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 65 65
No Clinical Signs, Symptoms or Conditions 19 19
No Known Impact Or Consequence To Patient 15 15
Low Oxygen Saturation 15 15
No Consequences Or Impact To Patient 10 10
No Information 6 6
Insufficient Information 3 3
Superficial (First Degree) Burn 2 2
Abnormal Blood Gases 1 1
Death 1 1
Overdose 1 1
Retinal Injury 1 1
Respiratory Arrest 1 1

Recalls
Manufacturer Recall Class Date Posted
1 CAREstream Medical LLC II Aug-22-2018
2 O-Two Medical Technologies, Inc. II Aug-22-2018
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