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
DATEX-OHMEDA, INC.
	SUBSTANTIALLY EQUIVALENT	1
PIRAMAL CRITCAL CARE, INC (FORMERLY MINRAD, INC)
	SUBSTANTIALLY EQUIVALENT	1
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	54	56
Insufficient Flow or Under Infusion	42	42
Unexpected Therapeutic Results	20	20
Inaccurate Delivery	20	20
Device Inoperable	13	13
Device Operates Differently Than Expected	13	13
Mechanical Problem	9	9
Excess Flow or Over-Infusion	9	9
Low Readings	7	7
Appropriate Term/Code Not Available	7	7
Break	6	6
Leak/Splash	5	5
Insufficient Information	4	4
Gas Output Problem	4	4
Gas/Air Leak	4	4
Output Problem	3	3
No Flow	3	3
Failure to Deliver	3	3
High Readings	3	3
Component Missing	3	3
Improper Flow or Infusion	3	3
No Display/Image	2	2
Fluid/Blood Leak	2	2
Defective Device	2	2
Electrical Overstress	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Device Handling Problem	2	2
Overheating of Device	2	2
Detachment of Device or Device Component	2	2
Connection Problem	2	2
Output below Specifications	1	1
Low Test Results	1	1
Mechanical Jam	1	1
Improper or Incorrect Procedure or Method	1	1
Loose or Intermittent Connection	1	1
Electrical /Electronic Property Problem	1	1
Self-Activation or Keying	1	1
Naturally Worn	1	1
Melted	1	1
Fracture	1	1
Defective Alarm	1	1
Activation Failure	1	1
No Apparent Adverse Event	1	1
Sticking	1	1
Device Emits Odor	1	1
Computer Operating System Problem	1	1
Inaccurate Flow Rate	1	1
Application Program Problem: Medication Error	1	1
Chemical Spillage	1	1
Failure to Align	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	148	148
No Patient Involvement	37	37
No Consequences Or Impact To Patient	23	23
No Known Impact Or Consequence To Patient	20	22
Awareness during Anaesthesia	15	15
Insufficient Information	4	4
High Blood Pressure/ Hypertension	3	3
No Information	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Chemical Exposure	2	2
Low Blood Pressure/ Hypotension	2	2
Syncope/Fainting	1	1
Red Eye(s)	1	1
No Code Available	1	1
Abnormal Blood Gases	1	1
Dizziness	1	1
Cardiac Arrest	1	1
Neurological Deficit/Dysfunction	1	1
Palpitations	1	1
Paresthesia	1	1
Burn(s)	1	1
Burning Sensation	1	1
Pain	1	1
Shock, Traumatic	1	1
Convulsion/Seizure	1	1
Inadequate Pain Relief	1	1
Low Oxygen Saturation	1	1