TPLC - Total Product Life Cycle

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Device	vaporizer, anesthesia, non-heated
Product Code	CAD
Regulation Number	868.5880
Device Class	2

Premarket Reviews
Manufacturer	Decision
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Infusion or Flow Problem	83	83
Output below Specifications	78	78
Insufficient Flow or Under Infusion	73	73
Inaccurate Delivery	21	21
Unexpected Therapeutic Results	18	18
Excess Flow or Over-Infusion	12	12
Low Readings	9	9
Gas/Air Leak	4	4
Improper Flow or Infusion	4	4
Gas Output Problem	4	4
Mechanical Problem	3	3
Insufficient Information	3	3
Output above Specifications	3	3
Use of Device Problem	3	3
No Display/Image	2	2
Defective Device	2	2
Electrical Overstress	2	2
Device Handling Problem	2	2
Detachment of Device or Device Component	2	2
No Apparent Adverse Event	2	2
Overheating of Device	2	2
No Flow	2	2
Fluid/Blood Leak	2	2
Leak/Splash	1	1
Restricted Flow rate	1	1
Therapeutic or Diagnostic Output Failure	1	1
Application Program Problem: Medication Error	1	1
Inaccurate Flow Rate	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Activation Failure	1	1
Fracture	1	1
Connection Problem	1	1
Electrical /Electronic Property Problem	1	1
Improper or Incorrect Procedure or Method	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	310	310
Awareness during Anaesthesia	5	5
Insufficient Information	4	4
No Consequences Or Impact To Patient	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Oversedation	2	2
Low Blood Pressure/ Hypotension	2	2
Syncope/Fainting	1	1
High Blood Pressure/ Hypertension	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