TPLC - Total Product Life Cycle

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Device	vaporizer, anesthesia, non-heated
Regulation Description	Anesthetic vaporizer.
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
Output below Specifications	3030	3031
Insufficient Flow or Under Infusion	172	173
Infusion or Flow Problem	86	86
Improper Flow or Infusion	43	43
Inaccurate Delivery	25	25
Excess Flow or Over-Infusion	21	21
Unexpected Therapeutic Results	19	19
Output above Specifications	19	19
No Apparent Adverse Event	11	11
Detachment of Device or Device Component	10	10
Low Readings	9	9
Therapeutic or Diagnostic Output Failure	7	7
Gas Output Problem	6	6
Insufficient Information	4	4
No Flow	3	3
Gas/Air Leak	3	3
Use of Device Problem	3	3
Leak/Splash	3	3
Overheating of Device	2	2
Fluid/Blood Leak	2	2
No Display/Image	2	2
Defective Device	2	2
Electrical Overstress	2	2
High Readings	2	2
Device Handling Problem	2	2
Activation Failure	1	1
Defective Component	1	1
Connection Problem	1	1
Deflation Problem	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Appropriate Term/Code Not Available	1	1
Unintended Movement	1	1
Electrical /Electronic Property Problem	1	1
Restricted Flow rate	1	1
Inaccurate Flow Rate	1	1
Fracture	1	1
Inflation Problem	1	1
Perivalvular Leak	1	1
Failure to Run on Battery	1	1
Energy Output 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	3395	3397
Insufficient Information	5	5
Oversedation	4	4
Low Blood Pressure/ Hypotension	4	4
Awareness during Anaesthesia	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
Convulsion/Seizure	1	1
Inadequate Pain Relief	1	1
Low Oxygen Saturation	1	1