TPLC - Total Product Life Cycle

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Device	spirometer, therapeutic (incentive)
Product Code	BWF
Regulation Number	868.5690
Device Class	2

Premarket Reviews
Manufacturer	Decision
D R BURTON HEALTHCARE, LLC
	SUBSTANTIALLY EQUIVALENT	1
ENCHANT TEK CO. LTD.
	SUBSTANTIALLY EQUIVALENT	1
LUNG TRAINERS, LLC
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
PEEP MEDICAL LLC DBA GO2 DEVICES
	SUBSTANTIALLY EQUIVALENT	1
RESPINOVA LTD.
	SUBSTANTIALLY EQUIVALENT	1
SMITHS MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
TELEFLEX MEDICAL, INC
	SUBSTANTIALLY EQUIVALENT	1
TRUDELL MEDICAL INTERNATIONAL
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Physical Resistance/Sticking	12	12
Material Separation	4	4
Gas/Air Leak	4	4
Adverse Event Without Identified Device or Use Problem	3	3
Break	2	2
Material Fragmentation	2	2
Leak/Splash	2	2
Loose or Intermittent Connection	1	1
Particulates	1	1
Labelling, Instructions for Use or Training Problem	1	1
Contamination	1	1
Crack	1	1
Failure to Cycle	1	1
Fracture	1	1
Packaging Problem	1	1
No Flow	1	1
Vibration	1	1
Device Damaged Prior to Use	1	1
Component Missing	1	1
Defective Device	1	1
Device Markings/Labelling Problem	1	1
Partial Blockage	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	16	16
No Clinical Signs, Symptoms or Conditions	15	15
Insufficient Information	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Cardiac Arrest	1	1
Death	1	1
Sepsis	1	1
Numbness	1	1
Respiratory Tract Infection	1	1
Low Oxygen Saturation	1	1
Bronchospasm	1	1
No Patient Involvement	1	1
Foreign Body In Patient	1	1
No Known Impact Or Consequence To Patient	1	1
No Code Available	1	1
Cough	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Smiths Medical ASD Inc.	II	Jan-15-2021