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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

MDR Year MDR Reports MDR Events
2020 11 11
2021 12 12
2022 13 13
2023 44 44
2024 255 256
2025 2639 2640

Device Problems MDRs with this Device Problem Events in those MDRs
Output below Specifications 2595 2596
Insufficient Flow or Under Infusion 167 168
Infusion or Flow Problem 88 88
Improper Flow or Infusion 43 43
Inaccurate Delivery 24 24
Excess Flow or Over-Infusion 20 20
Unexpected Therapeutic Results 19 19
No Apparent Adverse Event 11 11
Detachment of Device or Device Component 10 10
Low Readings 9 9
Output above Specifications 9 9
Therapeutic or Diagnostic Output Failure 7 7
Gas Output Problem 5 5
Insufficient Information 4 4
Gas/Air Leak 4 4
No Flow 3 3
Device Handling Problem 3 3
Use of Device Problem 3 3
Mechanical Problem 3 3
Leak/Splash 3 3
Electrical Overstress 2 2
Defective Device 2 2
Overheating of Device 2 2
No Display/Image 2 2
Fluid/Blood Leak 2 2
Application Program Problem: Medication Error 1 1
High Readings 1 1
Deflation Problem 1 1
Inaccurate Flow Rate 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Inflation Problem 1 1
Defective Component 1 1
Unintended Movement 1 1
Activation Failure 1 1
Energy Output Problem 1 1
Fracture 1 1
Perivalvular Leak 1 1
Appropriate Term/Code Not Available 1 1
Restricted Flow rate 1 1
Connection Problem 1 1
Electrical /Electronic Property Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Failure to Run on Battery 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2947 2949
Insufficient Information 5 5
Awareness during Anaesthesia 5 5
No Consequences Or Impact To Patient 4 4
Low Blood Pressure/ Hypotension 4 4
Oversedation 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Fecal Incontinence 2 2
High Blood Pressure/ Hypertension 1 1
Syncope/Fainting 1 1
Dizziness 1 1
Chemical Exposure 1 1
Paresthesia 1 1
No Patient Involvement 1 1
Pain 1 1
Shock, Traumatic 1 1
Convulsion/Seizure 1 1
Inadequate Pain Relief 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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