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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
BALDUS SEDATION GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 2
DEHAS MEDICAL SYSTEMS GMBH
  SUBSTANTIALLY EQUIVALENT 1
MAXTEC, LLC
  SUBSTANTIALLY EQUIVALENT 1
PARKER HANNIFIN
  SUBSTANTIALLY EQUIVALENT 1
PARKER HANNIFIN CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 26 26
2020 15 15
2021 33 33
2022 15 15
2023 19 19
2024 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 38 38
Leak/Splash 12 12
Output Problem 6 6
Fire 4 4
Device Alarm System 4 4
Therapeutic or Diagnostic Output Failure 4 4
Material Integrity Problem 4 4
No Apparent Adverse Event 4 4
No Audible Alarm 4 4
Protective Measures Problem 3 3
Inaccurate Delivery 3 3
Infusion or Flow Problem 3 3
Gas/Air Leak 3 3
No Flow 3 3
Gas Output Problem 3 3
Appropriate Term/Code Not Available 2 2
Medical Gas Supply Problem 2 2
Contamination 2 2
Positioning Problem 2 2
Defective Device 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Failure to Deliver 1 1
Output above Specifications 1 1
High Readings 1 1
Insufficient Information 1 1
No Device Output 1 1
Display or Visual Feedback Problem 1 1
Loose or Intermittent Connection 1 1
Improper or Incorrect Procedure or Method 1 1
No Audible Prompt/Feedback 1 1
Misconnection 1 1
Device Handling Problem 1 1
Failure to Align 1 1
Improper Flow or Infusion 1 1
Delayed Alarm 1 1
Melted 1 1
Device Damaged by Another Device 1 1
Misassembly During Maintenance/Repair 1 1
Crack 1 1
Break 1 1
Volume Accuracy Problem 1 1
No Display/Image 1 1
Material Frayed 1 1
Pressure Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 67 67
Low Oxygen Saturation 15 15
No Patient Involvement 12 12
Insufficient Information 8 8
No Consequences Or Impact To Patient 7 7
No Known Impact Or Consequence To Patient 5 5
No Information 3 3
Superficial (First Degree) Burn 2 2
Death 1 1
Respiratory Arrest 1 1
Retinal Injury 1 1
Hypoxia 1 1

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