TPLC - Total Product Life Cycle

show TPLC since

Device	monitor, carbon-dioxide, cutaneous
Product Code	LKD
Regulation Number	868.2480
Device Class	2

Premarket Reviews
Manufacturer	Decision
PERIMED AB
	SUBSTANTIALLY EQUIVALENT	1
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN
	SUBSTANTIALLY EQUIVALENT	1
RADIOMETER MEDICAL APS
	SUBSTANTIALLY EQUIVALENT	1
SENTEC AG
	SUBSTANTIALLY EQUIVALENT	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	19	19
Insufficient Information	9	9
Fracture	5	5
Improper or Incorrect Procedure or Method	4	4
Device Alarm System	3	3
Use of Device Problem	3	3
Material Deformation	3	3
Break	2	2
Malposition of Device	2	2
Entrapment of Device	2	2
Positioning Problem	1	1
Smoking	1	1
Device Operates Differently Than Expected	1	1
Device Dislodged or Dislocated	1	1
Failure to Disconnect	1	1
Electrical /Electronic Property Problem	1	1
Device Displays Incorrect Message	1	1
Out-Of-Box Failure	1	1
Thermal Decomposition of Device	1	1
Incorrect Measurement	1	1
Sticking	1	1
Fire	1	1
Off-Label Use	1	1
Patient Device Interaction Problem	1	1
Difficult to Remove	1	1
High Readings	1	1
Failure to Align	1	1
Device Handling Problem	1	1
Calibration Problem	1	1
Noise, Audible	1	1
Temperature Problem	1	1
Detachment Of Device Component	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Burn(s)	18	18
Injury	15	15
Partial thickness (Second Degree) Burn	13	13
No Known Impact Or Consequence To Patient	11	11
No Code Available	5	5
Apnea	4	4
No Information	4	4
No Clinical Signs, Symptoms or Conditions	3	3
Burning Sensation	3	3
Discomfort	3	3
Unspecified Infection	2	2
Burn, Thermal	2	2
Bacterial Infection	2	2
Failure of Implant	1	1
Localized Skin Lesion	1	1
Staphylococcus Aureus	1	1
No Patient Involvement	1	1
Insufficient Information	1	1
No Consequences Or Impact To Patient	1	1