TPLC - Total Product Life Cycle

• Device: cart, emergency, cardiopulmonary (excluding equipment)
• Product Code: BZN
• Regulation Number: 868.6175
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2019	8	8
2020	4	4
2021	8	8
2022	29	29
2023	12	12

Device Problems	MDRs with this Device Problem	Events in those MDRs
Mechanical Problem	15	15
No Display/Image	13	13
Output Problem	8	8
Unintended Movement	8	8
Thermal Decomposition of Device	7	7
Loss of Power	7	7
Intermittent Energy Output	5	5
Ambient Temperature Problem	4	4
Overheating of Device	4	4
Material Discolored	4	4
Positioning Problem	3	3
Therapeutic or Diagnostic Output Failure	2	2
Device Fell	2	2
Device Slipped	2	2
Energy Output Problem	2	2
Failure to Power Up	1	1
Melted	1	1
Nonstandard Device	1	1
Unintended System Motion	1	1
Break	1	1
Degraded	1	1
Difficult or Delayed Positioning	1	1
Display or Visual Feedback Problem	1	1
Fracture	1	1
Loose or Intermittent Connection	1	1
Unstable	1	1
Arcing	1	1
Sparking	1	1
Electrical Shorting	1	1
Material Integrity Problem	1	1
Material Twisted/Bent	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Intermittent Loss of Power	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	46	46
Insufficient Information	12	12
No Known Impact Or Consequence To Patient	10	10
Cough	1	1
Headache	1	1
Laceration(s)	1	1
No Consequences Or Impact To Patient	1	1
Superficial (First Degree) Burn	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Stryker Corporation	II	Mar-05-2020