TPLC - Total Product Life Cycle

show TPLC since

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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Gas/Air Leak	5	5
Defective Component	4	4
Detachment of Device or Device Component	4	4
Disconnection	2	2
Separation Problem	2	2
Output Problem	2	2
Physical Resistance/Sticking	2	2
Key or Button Unresponsive/not Working	2	2
Use of Device Problem	2	2
Component Missing	2	2
Connection Problem	2	2
Human-Device Interface Problem	2	2
Loose or Intermittent Connection	2	2
Fitting Problem	1	1
Pressure Problem	1	1
Break	1	1
Mechanical Problem	1	1
Volume Accuracy Problem	1	1
Tidal Volume Fluctuations	1	1
Expiration Date Error	1	1
Defective Device	1	1
Material Integrity Problem	1	1
Output above Specifications	1	1
Difficult to Remove	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Difficult to Insert	1	1
No Pressure	1	1
Obstruction of Flow	1	1
Device Difficult to Maintain	1	1
Inaccurate Flow Rate	1	1
Blocked Connection	1	1
Misconnection	1	1
Labelling, Instructions for Use or Training Problem	1	1
Material Separation	1	1
Fracture	1	1
Gas Output Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	18	18
Insufficient Information	5	5
No Consequences Or Impact To Patient	5	5
No Known Impact Or Consequence To Patient	4	4
Respiratory Insufficiency	4	4
Unintended Extubation	3	3
Death	1	1
Cardiac Arrest	1	1
Overinflation of Lung	1	1
Low Oxygen Saturation	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Westmed, Inc.	II	Jun-26-2020