TPLC - Total Product Life Cycle

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

Premarket Reviews
Manufacturer	Decision
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
TIDAL MEDICAL TECHNOLOGIES, LLC
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	4	4
Physical Resistance/Sticking	3	3
Gas/Air Leak	3	3
Partial Blockage	2	2
Leak/Splash	2	2
Contamination /Decontamination Problem	1	1
Failure to Cycle	1	1
Fracture	1	1
Contamination	1	1
Mechanical Problem	1	1
Packaging Problem	1	1
Ventilation Problem in Device Environment	1	1
Device Markings/Labelling Problem	1	1
Device Damaged Prior to Use	1	1
Component Missing	1	1
Material Fragmentation	1	1
Defective Device	1	1
Loose or Intermittent Connection	1	1
Crack	1	1
No Flow	1	1
Defective Component	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	24	24
Insufficient Information	3	3
Cough	2	2
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	2	2
Foreign Body In Patient	1	1
Atrial Fibrillation	1	1
Impaired Healing	1	1
Hemorrhage/Blood Loss/Bleeding	1	1
Emotional Changes	1	1
Numbness	1	1
Choking	1	1
Loss of consciousness	1	1
Fatigue	1	1
Cardiac Arrest	1	1
Unspecified Musculoskeletal problem	1	1
Respiratory Tract Infection	1	1
Sepsis	1	1
Pain	1	1
Low Oxygen Saturation	1	1
Bronchospasm	1	1

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