TPLC - Total Product Life Cycle

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Device	calculator, pulmonary function data
Product Code	BZC
Regulation Number	868.1880
Device Class	2

Premarket Reviews
Manufacturer	Decision
CAREFUSION GERMANY 234 GMBH
	SUBSTANTIALLY EQUIVALENT	2
COSMED S.R.L.
	SUBSTANTIALLY EQUIVALENT	1
INNOVISION A/S
	SUBSTANTIALLY EQUIVALENT	1
PULMONE ADVANCED MEDICAL DEVICES, LTD
	SUBSTANTIALLY EQUIVALENT	2
VYAIRE MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
VYAIRE MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	1
VYAIRE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Mechanical Problem	9	9
Device Stops Intermittently	3	3
Fumes or Vapors	3	3
Adverse Event Without Identified Device or Use Problem	3	3
Electrical Shorting	2	2
Gas/Air Leak	2	2
Insufficient Information	2	2
Defective Device	2	2
Smoking	2	2
Computer Software Problem	2	2
Electrical /Electronic Property Problem	1	1
Gas Output Problem	1	1
Leak/Splash	1	1
Device Emits Odor	1	1
Output above Specifications	1	1
Overheating of Device	1	1
Product Quality Problem	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Component Incompatible	1	1
Use of Device Problem	1	1
Improper or Incorrect Procedure or Method	1	1
Contamination /Decontamination Problem	1	1
Device Operates Differently Than Expected	1	1
Explosion	1	1
Non Reproducible Results	1	1
Intermittent Communication Failure	1	1
Improper Device Output	1	1
Material Integrity Problem	1	1
Temperature Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	17	17
No Patient Involvement	7	7
No Consequences Or Impact To Patient	3	3
Discomfort	2	2
Dyspnea	2	2
No Known Impact Or Consequence To Patient	2	2
Convulsion/Seizure	1	1
Abrasion	1	1
Bruise/Contusion	1	1
Headache	1	1
Low Blood Pressure/ Hypotension	1	1
Laceration(s)	1	1
Dizziness	1	1
Sore Throat	1	1
Loss of consciousness	1	1
Tooth Fracture	1	1
Decreased Respiratory Rate	1	1
Electric Shock	1	1