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	3118	3119
Insufficient Flow or Under Infusion	185	186
Infusion or Flow Problem	86	86
Improper Flow or Infusion	43	43
Inaccurate Delivery	24	24
Excess Flow or Over-Infusion	23	23
Output above Specifications	22	22
Unexpected Therapeutic Results	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	8	8
Leak/Splash	6	6
Gas Output Problem	6	6
Use of Device Problem	3	3
Insufficient Device Problem Information	3	3
No Display/Image	2	2
Electrical Overstress	2	2
High Readings	2	2
Gas/Air Leak	2	2
Device Handling Problem	2	2
Overheating of Device	2	2
No Flow	2	2
Failure to Run on Battery	2	2
Restricted Flow rate	1	1
Energy Output Problem	1	1
Deflation Problem	1	1
Inaccurate Flow Rate	1	1
Inflation Problem	1	1
Partial Blockage	1	1
Appropriate Device Problem Term/Code Not Available	1	1
Activation Failure	1	1
Fracture	1	1
Perivalvular Leak	1	1
Electrical /Electronic Property Problem	1	1
Improper or Incorrect Procedure or Method	1	1
Fluid/Blood Leak	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3499	3501
Insufficient Information	9	9
Oversedation	5	5
Low Blood Pressure/ Hypotension	4	4
Awareness during Anaesthesia	3	3
Fecal Incontinence	2	2
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	2	2
High Blood Pressure/ Hypertension	1	1
Syncope/Fainting	1	1
Dizziness	1	1
Chemical Exposure	1	1
Paresthesia	1	1
Hypoxia	1	1
Convulsion/Seizure	1	1
Inadequate Pain Relief	1	1
Low Oxygen Saturation	1	1