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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
Product CodeBZR
Regulation Number 868.5330
Device Class 2


Premarket Reviews
ManufacturerDecision
O-TWO MEDICAL TECHNOLOGIES INC.
  SUBSTANTIALLY EQUIVALENT 1
PARKER HANNIFIN
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 22 22
2018 24 24
2019 26 26
2020 15 15
2021 33 33
2022 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 29 29
Device Operates Differently Than Expected 19 19
Device Alarm System 11 11
Leak/Splash 9 9
Output Problem 7 7
Therapeutic or Diagnostic Output Failure 5 5
Inaccurate Delivery 5 5
Fire 5 5
No Audible Alarm 4 4
Material Integrity Problem 4 4
No Apparent Adverse Event 4 4
No Flow 3 3
Protective Measures Problem 3 3
Calibration Problem 3 3
Infusion or Flow Problem 3 3
Gas Leak 2 2
Improper Device Output 2 2
Failure to Calibrate 2 2
Loose or Intermittent Connection 2 2
Defective Device 2 2
Contamination 2 2
Medical Gas Supply Problem 2 2
Positioning Problem 1 1
Programming Issue 1 1
Appropriate Term/Code Not Available 1 1
Misassembly During Maintenance/Repair 1 1
Crack 1 1
Break 1 1
Material Frayed 1 1
Gas Output Problem 1 1
Kinked 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
Delayed Alarm 1 1
Incorrect Measurement 1 1
Incorrect Or Inadequate Test Results 1 1
High Readings 1 1
Improper Flow or Infusion 1 1
Free or Unrestricted Flow 1 1
Material Twisted/Bent 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 47 47
No Clinical Signs, Symptoms or Conditions 38 38
Low Oxygen Saturation 15 15
No Known Impact Or Consequence To Patient 10 10
No Consequences Or Impact To Patient 9 9
No Information 4 4
Insufficient Information 4 4
Superficial (First Degree) Burn 2 2
Respiratory Arrest 1 1
Abnormal Blood Gases 1 1
Death 1 1
Retinal Injury 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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