TPLC - Total Product Life Cycle

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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Appropriate Term/Code Not Available	14	14
Electrical /Electronic Property Problem	7	7
Temperature Problem	7	7
Sparking	6	6
Fire	6	6
Smoking	5	5
Adverse Event Without Identified Device or Use Problem	5	5
Insufficient Information	4	4
Unintended Movement	3	3
Thermal Decomposition of Device	3	3
Break	2	2
Material Integrity Problem	2	2
Detachment of Device or Device Component	2	2
Improper or Incorrect Procedure or Method	2	2
Device Slipped	1	1
Component or Accessory Incompatibility	1	1
Mechanical Problem	1	1
Collapse	1	1
Material Puncture/Hole	1	1
Device Fell	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Positioning Problem	1	1
Failure to Power Up	1	1
Use of Device Problem	1	1
Material Twisted/Bent	1	1
Sharp Edges	1	1
Material Deformation	1	1
Device Emits Odor	1	1
Inadequacy of Device Shape and/or Size	1	1
Material Protrusion/Extrusion	1	1
Activation Failure	1	1
Explosion	1	1
Melted	1	1
Overheating of Device	1	1
Mechanical Jam	1	1
No Device Output	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	27	27
Fall	12	12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	10	10
Laceration(s)	7	7
Bone Fracture(s)	5	5
No Known Impact Or Consequence To Patient	5	5
Burn(s)	4	4
Electric Shock	3	3
Pain	3	3
Pressure Sores	2	2
Hip Fracture	1	1
Multiple Fractures	1	1
No Patient Involvement	1	1
Insufficient Information	1	1
Physical Entrapment	1	1
Missing Value Reason	1	1
Cough	1	1
Unspecified Respiratory Problem	1	1
Tissue Breakdown	1	1