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
CAREFUSION GERMANY 234 GMBH
	SUBSTANTIALLY EQUIVALENT	3
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
NDD MEDIZITECHNIK AG
	SUBSTANTIALLY EQUIVALENT	2
SHAPE MEDICAL SYSTEMS, INC
	SUBSTANTIALLY EQUIVALENT	2
VIRTUS TECHNOLOGY APS
	SUBSTANTIALLY EQUIVALENT	1
VITALOGRAPH IRELAND LTD.
	SUBSTANTIALLY EQUIVALENT	1
1. K221030 Model 9100 PFT/DICO

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

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	43	43
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
Red Eye(s)	1	1
Fatigue	1	1
Dizziness	1	1
Malaise	1	1
Irritation	1	1
Injury	1	1
Insufficient Information	1	1
Hypoglycemia	1	1
Thromboembolism	1	1
Fainting	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
3	Shape Medical Systems, Inc	II	Jul-14-2014