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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device vaporizer, anesthesia, non-heated
Regulation Description Anesthetic vaporizer.
Product CodeCAD
Regulation Number 868.5880
Device Class 2


Premarket Reviews
ManufacturerDecision
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K240375  V80 Anesthetic Vaporizer (V80)

MDR Year MDR Reports MDR Events
2020 11 11
2021 12 12
2022 13 13
2023 44 44
2024 255 255
2025 168 168

Device Problems MDRs with this Device Problem Events in those MDRs
Output below Specifications 241 241
Infusion or Flow Problem 83 83
Insufficient Flow or Under Infusion 76 76
Inaccurate Delivery 22 22
Unexpected Therapeutic Results 18 18
Excess Flow or Over-Infusion 12 12
Low Readings 9 9
Improper Flow or Infusion 5 5
Gas/Air Leak 4 4
Output above Specifications 4 4
Gas Output Problem 4 4
Use of Device Problem 3 3
No Apparent Adverse Event 3 3
Insufficient Information 3 3
Mechanical Problem 3 3
Device Handling Problem 2 2
No Flow 2 2
No Display/Image 2 2
Therapeutic or Diagnostic Output Failure 2 2
Overheating of Device 2 2
Defective Device 2 2
Electrical Overstress 2 2
Fluid/Blood Leak 2 2
Detachment of Device or Device Component 2 2
Improper or Incorrect Procedure or Method 1 1
Connection Problem 1 1
Application Program Problem: Medication Error 1 1
Deflation Problem 1 1
Leak/Splash 1 1
Activation Failure 1 1
Fracture 1 1
Electrical /Electronic Property Problem 1 1
Inaccurate Flow Rate 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Restricted Flow rate 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 480 480
Awareness during Anaesthesia 5 5
No Consequences Or Impact To Patient 4 4
Insufficient Information 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Oversedation 2 2
Low Blood Pressure/ Hypotension 2 2
No Patient Involvement 1 1
Inadequate Pain Relief 1 1
Paresthesia 1 1
Shock, Traumatic 1 1
Dizziness 1 1
Syncope/Fainting 1 1
High Blood Pressure/ Hypertension 1 1
Convulsion/Seizure 1 1
Pain 1 1
Chemical Exposure 1 1
Low Oxygen Saturation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 GE Medical Systems, LLC II Jan-07-2025
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