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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

MDR Year MDR Reports MDR Events
2019 26 26
2020 15 15
2021 33 33
2022 15 15
2023 19 19
2024 2 2

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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 57 57
Low Oxygen Saturation 14 14
No Patient Involvement 12 12
No Consequences Or Impact To Patient 7 7
Insufficient Information 7 7
No Known Impact Or Consequence To Patient 5 5
No Information 3 3
Superficial (First Degree) Burn 2 2
Death 1 1
Hypoxia 1 1
Retinal Injury 1 1
Respiratory Arrest 1 1

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