TPLC - Total Product Life Cycle

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Device	calculator, predicted values, pulmonary function
Product Code	BTY
Regulation Number	868.1890
Device Class	2

Premarket Reviews
Manufacturer	Decision
COSMED SRL
	SUBSTANTIALLY EQUIVALENT	1
ERESEARCHTECHNOLOGY GMBH
	SUBSTANTIALLY EQUIVALENT	3
GUANGZHOU HOMESUN MEDICAL TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
MEDICAL GRAPHICS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
NDD MEDIZINTECHNIK AG
	SUBSTANTIALLY EQUIVALENT	1
SHAPE MEDICAL SYSTEMS, INC
	SUBSTANTIALLY EQUIVALENT	1
VIRTUS TECHNOLOGY APS
	SUBSTANTIALLY EQUIVALENT	1
VITALOGRAPH IRELAND LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
High Test Results	27	27
Device Stops Intermittently	11	11
Calibration Problem	8	8
Smoking	7	7
Break	6	6
Overheating of Device	3	3
Failure to Calibrate	3	3
Connection Problem	3	3
Device Operational Issue	3	3
Incorrect, Inadequate or Imprecise Result or Readings	3	3
Temperature Problem	2	2
Device Displays Incorrect Message	2	2
Loose or Intermittent Connection	2	2
Incorrect Software Programming Calculations	2	2
Melted	2	2
Computer Operating System Problem	2	2
Failure to Power Up	2	2
Incorrect Or Inadequate Test Results	2	2
Battery Problem	2	2
Sparking	2	2
Device Operates Differently Than Expected	2	2
Patient Device Interaction Problem	1	1
Defective Device	1	1
Charred	1	1
Patient Data Problem	1	1
Gas/Air Leak	1	1
Output Problem	1	1
Thermal Decomposition of Device	1	1
Application Program Problem: Dose Calculation Error	1	1
Mechanical Problem	1	1
Environmental Compatibility Problem	1	1
Misconnection	1	1
Fumes or Vapors	1	1
Grounding Malfunction	1	1
Computer Software Problem	1	1
Power Problem	1	1
Incorrect Measurement	1	1
Electrical /Electronic Property Problem	1	1
Programming Issue	1	1
Environmental Particulates	1	1
Electrical Power Problem	1	1
Detachment Of Device Component	1	1
Component Falling	1	1
Application Program Problem	1	1
Low Test Results	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	42	42
No Patient Involvement	24	24
No Consequences Or Impact To Patient	16	16
No Clinical Signs, Symptoms or Conditions	7	7
No Information	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Fatigue	1	1
Red Eye(s)	1	1
Dizziness	1	1
Malaise	1	1
Irritation	1	1
Injury	1	1
Insufficient Information	1	1
Hypoglycemia	1	1
Fainting	1	1
Thromboembolism	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	NDDd Medical Technologies, Inc.	II	Dec-03-2019
2	Shape Medical Systems, Inc	II	Feb-05-2015