TPLC - Total Product Life Cycle

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Device	attachment, breathing, positive end expiratory pressure
Product Code	BYE
Regulation Number	868.5965
Device Class	2

Premarket Reviews
Manufacturer	Decision
A PLUS MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
AIRWAYS DEVELOPMENT, LLC
	SUBSTANTIALLY EQUIVALENT	1
BESMED HEALTH BUSINESS CORP.
	SUBSTANTIALLY EQUIVALENT	1
DRAEGER MEDICAL AG & CO. KG
	SUBSTANTIALLY EQUIVALENT	1
GALEMED CORP.
	SUBSTANTIALLY EQUIVALENT	1
MERCURY ENTERPRIZES DBA MERCURY MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
MERCURY MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
NEOFORCE GROUP, INC.
	SUBSTANTIALLY EQUIVALENT	1
O-TWO MEDICAL TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
S & T MEDICAL TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
SEN MU TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Gas/Air Leak	6	6
Component Missing	5	5
Detachment of Device or Device Component	4	4
Misconnection	4	4
Defective Component	4	4
Pressure Problem	4	4
Break	3	3
Material Discolored	3	3
Disconnection	3	3
Fracture	3	3
Misassembled	3	3
Blocked Connection	3	3
Connection Problem	3	3
Fitting Problem	2	2
Device Misassembled During Manufacturing /Shipping	2	2
Device Operates Differently Than Expected	2	2
Loose or Intermittent Connection	2	2
Use of Device Problem	2	2
Key or Button Unresponsive/not Working	2	2
Output Problem	2	2
No Flow	2	2
Human-Device Interface Problem	2	2
Manufacturing, Packaging or Shipping Problem	1	1
Material Integrity Problem	1	1
Medical Gas Supply Problem	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Temperature Problem	1	1
Volume Accuracy Problem	1	1
Improper or Incorrect Procedure or Method	1	1
Mechanical Problem	1	1
Obstruction of Flow	1	1
Expiration Date Error	1	1
Low Battery	1	1
Defective Device	1	1
Device Packaging Compromised	1	1
Activation, Positioning or Separation Problem	1	1
Gas Output Problem	1	1
Gradient Increase	1	1
Insufficient Heating	1	1
Difficult to Insert	1	1
Labelling, Instructions for Use or Training Problem	1	1
Leak/Splash	1	1
Inaccurate Flow Rate	1	1
Detachment Of Device Component	1	1
Disassembly	1	1
Output above Specifications	1	1
Loss of Power	1	1
Unable to Obtain Readings	1	1
Difficult to Remove	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Material Separation	1	1
Tidal Volume Fluctuations	1	1
Device Inoperable	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	16	16
No Consequences Or Impact To Patient	9	9
No Known Impact Or Consequence To Patient	8	8
Insufficient Information	5	5
No Information	3	3
Unintended Extubation	3	3
Cardiopulmonary Arrest	3	3
Low Oxygen Saturation	3	3
Death	2	2
Hypoventilation	2	2
No Patient Involvement	2	2
Pain	1	1
Pneumothorax	1	1
Respiratory Distress Syndrome of Newborns	1	1
Ventricular Fibrillation	1	1
Aneurysm	1	1
Apnea	1	1
Arrhythmia	1	1
Atrial Fibrillation	1	1
Cardiac Arrest	1	1
Fatigue	1	1
Sleep Dysfunction	1	1
Chronic Obstructive Pulmonary Disease (COPD)	1	1
Toxicity	1	1
Overinflation of Lung	1	1