TPLC - Total Product Life Cycle

show TPLC since

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
Inaccurate Delivery	20	20
Unexpected Therapeutic Results	20	20
Device Operates Differently Than Expected	13	13
Device Inoperable	13	13
Mechanical Problem	9	9
Excess Flow or Over-Infusion	9	9
Appropriate Term/Code Not Available	7	7
Low Readings	7	7
Break	6	6
Leak/Splash	5	5
Gas Output Problem	4	4
Insufficient Information	4	4
Gas/Air Leak	4	4
High Readings	3	3
Failure to Deliver	3	3
No Flow	3	3
Output Problem	3	3
Component Missing	3	3
Improper Flow or Infusion	3	3
Overheating of Device	2	2
Connection Problem	2	2
Detachment of Device or Device Component	2	2
Device Handling Problem	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Electrical Overstress	2	2
Defective Device	2	2
No Display/Image	2	2
Fluid/Blood Leak	2	2
Chemical Spillage	1	1
Application Program Problem: Medication Error	1	1
Use of Device Problem	1	1
Failure to Align	1	1
Inaccurate Flow Rate	1	1
Restricted Flow rate	1	1
Computer Operating System Problem	1	1
Device Markings/Labelling Problem	1	1
Device Emits Odor	1	1
Output below Specifications	1	1
Activation Failure	1	1
Sticking	1	1
No Apparent Adverse Event	1	1
Low Test Results	1	1
Melted	1	1
Naturally Worn	1	1
Defective Alarm	1	1
Self-Activation or Keying	1	1
Fracture	1	1
Incorrect, Inadequate or Imprecise Result or Readings	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