TPLC - Total Product Life Cycle

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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	2

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
Entrapment of Device	2	2
Break	2	2
Malposition of Device	2	2
Calibration Problem	1	1
Device Operates Differently Than Expected	1	1
Device Dislodged or Dislocated	1	1
Out-Of-Box Failure	1	1
High Readings	1	1
Failure to Align	1	1
Failure to Disconnect	1	1
Device Displays Incorrect Message	1	1
Thermal Decomposition of Device	1	1
Detachment Of Device Component	1	1
Electrical /Electronic Property Problem	1	1
Incorrect Measurement	1	1
Off-Label Use	1	1
Difficult to Remove	1	1
Smoking	1	1
Sticking	1	1
Fire	1	1
Device Handling Problem	1	1
Noise, Audible	1	1
Patient Device Interaction Problem	1	1
Positioning Problem	1	1
Temperature Problem	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
No Information	4	4
Apnea	4	4
Burning Sensation	3	3
Discomfort	3	3
No Clinical Signs, Symptoms or Conditions	3	3
Burn, Thermal	2	2
Unspecified Infection	2	2
Bacterial Infection	2	2
Failure of Implant	1	1
Staphylococcus Aureus	1	1
No Consequences Or Impact To Patient	1	1
No Patient Involvement	1	1
Localized Skin Lesion	1	1
Insufficient Information	1	1