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	34	36
Insufficient Flow or Under Infusion	28	28
Unexpected Therapeutic Results	19	19
Inaccurate Delivery	14	14
Device Operates Differently Than Expected	13	13
Device Inoperable	13	13
Mechanical Problem	9	9
Appropriate Term/Code Not Available	7	7
Break	6	6
Leak/Splash	5	5
Insufficient Information	4	4
Gas/Air Leak	4	4
Improper Flow or Infusion	3	3
No Flow	3	3
Output Problem	3	3
Gas Output Problem	3	3
Excess Flow or Over-Infusion	3	3
Component Missing	3	3
Failure to Deliver	3	3
High Readings	3	3
Electrical Overstress	2	2
Connection Problem	2	2
Defective Device	2	2
No Display/Image	2	2
Overheating of Device	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Device Handling Problem	2	2
Activation Failure	1	1
Defective Alarm	1	1
Application Program Problem: Medication Error	1	1
No Apparent Adverse Event	1	1
Mechanical Jam	1	1
Naturally Worn	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Self-Activation or Keying	1	1
Sticking	1	1
Stretched	1	1
Use of Device Problem	1	1
Improper or Incorrect Procedure or Method	1	1
Electrical /Electronic Property Problem	1	1
Restricted Flow rate	1	1
Inaccurate Flow Rate	1	1
Fluid/Blood Leak	1	1
Fracture	1	1
Loose or Intermittent Connection	1	1
Chemical Spillage	1	1
Computer Operating System Problem	1	1
Low Test Results	1	1
Detachment of Device or Device Component	1	1
Device Markings/Labelling Problem	1	1
Low Readings	1	1
Failure to Align	1	1
Fumes or Vapors	1	1
Melted	1	1
Device Emits Odor	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	92	92
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
No Information	3	3
High Blood Pressure/ Hypertension	3	3
Insufficient Information	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Low Blood Pressure/ Hypotension	2	2
Chemical Exposure	2	2
Abnormal Blood Gases	1	1
Burn(s)	1	1
Cardiac Arrest	1	1
No Code Available	1	1
Convulsion/Seizure	1	1
Syncope/Fainting	1	1
Paresthesia	1	1
Neurological Deficit/Dysfunction	1	1
Pain	1	1
Red Eye(s)	1	1
Burning Sensation	1	1
Dizziness	1	1
Shock, Traumatic	1	1
Inadequate Pain Relief	1	1
Palpitations	1	1
Low Oxygen Saturation	1	1