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	15	15
Sparking	10	10
Smoking	10	10
Fire	9	9
Electrical /Electronic Property Problem	9	9
Temperature Problem	6	6
Adverse Event Without Identified Device or Use Problem	5	5
Insufficient Information	4	4
Thermal Decomposition of Device	3	3
Break	2	2
Mechanical Problem	2	2
Unintended Electrical Shock	2	2
Device Fell	2	2
Material Integrity Problem	2	2
Use of Device Problem	2	2
Material Deformation	2	2
Melted	2	2
Mechanical Jam	2	2
Material Frayed	1	1
Collapse	1	1
Positioning Problem	1	1
Patient Device Interaction Problem	1	1
Failure to Power Up	1	1
Material Twisted/Bent	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
Unintended System Motion	1	1
Overheating of Device	1	1
Improper or Incorrect Procedure or Method	1	1
Arcing	1	1
No Device Output	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	37	37
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	10	10
Burn(s)	6	6
Fall	6	6
Electric Shock	5	5
Laceration(s)	5	5
Bone Fracture(s)	4	4
Insufficient Information	4	4
Physical Entrapment	4	4
Pain	3	3
Hip Fracture	2	2
Pressure Sores	2	2
Bruise/Contusion	2	2
Multiple Fractures	1	1
Abrasion	1	1
Neck Pain	1	1
Cough	1	1
Unspecified Respiratory Problem	1	1
Hemorrhage/Bleeding	1	1
Tissue Breakdown	1	1