TPLC - Total Product Life Cycle

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

MDR Year	MDR Reports	MDR Events
2018	10	10
2019	5	5
2020	5	5
2021	4	4
2022	10	10
2023	6	6

Device Problems	MDRs with this Device Problem	Events in those MDRs
Gas/Air Leak	6	6
Defective Component	4	4
Component Missing	4	4
Detachment of Device or Device Component	4	4
Material Discolored	3	3
Disconnection	2	2
Use of Device Problem	2	2
Loose or Intermittent Connection	2	2
Output Problem	2	2
Human-Device Interface Problem	2	2
Connection Problem	2	2
Break	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Obstruction of Flow	1	1
Expiration Date Error	1	1
Low Battery	1	1
Defective Device	1	1
Blocked Connection	1	1
Key or Button Unresponsive/not Working	1	1
Mechanical Problem	1	1
Misconnection	1	1
Output above Specifications	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
Volume Accuracy Problem	1	1
Improper or Incorrect Procedure or Method	1	1
Fitting Problem	1	1
Inaccurate Flow Rate	1	1
Fracture	1	1
Gas Output Problem	1	1
Difficult to Insert	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	14	14
No Consequences Or Impact To Patient	9	9
No Known Impact Or Consequence To Patient	5	5
Unintended Extubation	3	3
Insufficient Information	3	3
No Information	2	2
No Patient Involvement	2	2
Overinflation of Lung	1	1
Cardiac Arrest	1	1
Death	1	1
Fatigue	1	1

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