• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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
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
2025 11 11

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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 79 79
Low Oxygen Saturation 14 14
Insufficient Information 9 9
No Information 3 3
No Patient Involvement 2 2
No Consequences Or Impact To Patient 2 2
Superficial (First Degree) Burn 1 1
Respiratory Arrest 1 1
Hypoxia 1 1

-
-