TPLC - Total Product Life Cycle

show TPLC since

Device	bed, therapeutic, ac-powered, adjustable home-use
Product Code	LLI
Regulation Number	880.5100
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Detachment of Device or Device Component	76	76
Appropriate Term/Code Not Available	11	11
Temperature Problem	11	11
Adverse Event Without Identified Device or Use Problem	8	8
Fire	5	5
Electrical /Electronic Property Problem	4	4
Improper or Incorrect Procedure or Method	4	4
Unintended Movement	4	4
Insufficient Information	4	4
Thermal Decomposition of Device	3	3
Break	2	2
Material Puncture/Hole	2	2
Device Slipped	2	2
Smoking	2	2
Material Integrity Problem	2	2
Material Protrusion/Extrusion	1	1
Mechanical Jam	1	1
Positioning Problem	1	1
Human-Device Interface Problem	1	1
Installation-Related Problem	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Material Deformation	1	1
Activation Failure	1	1
Patient Device Interaction Problem	1	1
Component Misassembled	1	1
Explosion	1	1
Sharp Edges	1	1
Device Fell	1	1
Separation Problem	1	1
Misassembled During Installation	1	1
Use of Device Problem	1	1
Inadequacy of Device Shape and/or Size	1	1
Material Perforation	1	1
Sparking	1	1
Patient-Device Incompatibility	1	1
Component or Accessory Incompatibility	1	1
Collapse	1	1
Mechanical Problem	1	1
Melted	1	1
Device Emits Odor	1	1
No Device Output	1	1
Overheating of Device	1	1
No Apparent Adverse Event	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	74	74
Fall	26	26
No Clinical Signs, Symptoms or Conditions	17	17
No Known Impact Or Consequence To Patient	11	11
Laceration(s)	10	10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	7	7
Hematoma	4	4
Burn(s)	3	3
Bone Fracture(s)	2	2
Injury	2	2
Electric Shock	2	2
Swelling	2	2
No Patient Involvement	1	1
Pressure Sores	1	1
Physical Entrapment	1	1
Missing Value Reason	1	1
Cough	1	1
Unspecified Respiratory Problem	1	1
Multiple Fractures	1	1
Death	1	1
Eye Injury	1	1
Abrasion	1	1
Pain	1	1