TPLC - Total Product Life Cycle

show TPLC since

Device	cart, emergency, cardiopulmonary (excluding equipment)
Regulation Description	Cardiopulmonary emergency cart.
Product Code	BZN
Regulation Number	868.6175
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
No Display/Image	20	20
Mechanical Problem	19	19
Output Problem	9	9
Positioning Problem	7	7
Thermal Decomposition of Device	7	7
Unintended Movement	6	6
Loss of Power	6	6
Intermittent Energy Output	5	5
Material Discolored	4	4
Ambient Temperature Problem	4	4
Overheating of Device	4	4
Electrical Power Problem	3	3
Device Slipped	2	2
Break	2	2
Energy Output Problem	2	2
Unstable	1	1
Sparking	1	1
Fire	1	1
Device Damaged Prior to Use	1	1
Smoking	1	1
Material Integrity Problem	1	1
Degraded	1	1
Failure to Power Up	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Difficult or Delayed Positioning	1	1
Product Quality Problem	1	1
Electrical Shorting	1	1
Fracture	1	1
Melted	1	1
Unintended System Motion	1	1
Connection Problem	1	1
Display or Visual Feedback Problem	1	1
Electrical /Electronic Property Problem	1	1
Loose or Intermittent Connection	1	1
Arcing	1	1
Intermittent Loss of Power	1	1
No Device Output	1	1
Temperature Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	62	62
Insufficient Information	12	12
No Known Impact Or Consequence To Patient	2	2
Superficial (First Degree) Burn	1	1
Laceration(s)	1	1
Cough	1	1
No Consequences Or Impact To Patient	1	1
Headache	1	1

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