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
Electrical /Electronic Property Problem	174	174
Mechanical Problem	136	136
Power Problem	56	56
Noise, Audible	47	47
Mechanical Jam	43	43
Key or Button Unresponsive/not Working	42	42
No Apparent Adverse Event	39	39
Mechanics Altered	36	36
Failure to Power Up	28	28
Insufficient Device Problem Information	26	26
Unintended Movement	22	22
Appropriate Device Problem Term/Code Not Available	21	21
Failure to Cycle	16	16
Positioning Problem	15	15
Break	13	13
Failure to Read Input Signal	13	13
Material Integrity Problem	12	12
Complete Loss of Power	11	11
Fire	11	11
Sparking	11	11
Activation Problem	11	11
Activation Failure	10	10
Material Frayed	9	9
Intermittent Loss of Power	9	9
Smoking	9	9
Temperature Problem	9	9
Detachment of Device or Device Component	8	8
Material Twisted/Bent	7	7
Physical Resistance/Sticking	6	6
Loose or Intermittent Connection	5	5
Adverse Event Without Identified Device or Use Problem	5	5
Material Separation	5	5
Defective Component	5	5
Fracture	4	4
Product Quality Problem	4	4
Use of Device Problem	4	4
Electrical Power Problem	3	3
Electrical Shorting	3	3
Failure to Eject	3	3
Connection Problem	3	3
Material Deformation	3	3
Unstable	3	3
Fitting Problem	3	3
Crack	3	3
Circuit Failure	3	3
Communication or Transmission Problem	2	2
Deformation Due to Compressive Stress	2	2
Explosion	2	2
Vibration	2	2
Inadequacy of Device Shape and/or Size	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	796	796
Insufficient Information	24	24
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	13	13
Fall	9	9
Burn(s)	6	6
Pain	6	6
Laceration(s)	6	6
Electric Shock	5	5
Bone Fracture(s)	4	4
Physical Entrapment	4	4
Pressure Sore/Ulcer	3	3
Abrasion	3	3
Bruise/Contusion	3	3
Hip Fracture	2	2
Multiple Fractures	1	1
Cellulitis	1	1
Dehydration	1	1
Tissue Breakdown	1	1
Neck Pain	1	1
Osteomyelitis	1	1
Hemorrhage/Blood Loss/Bleeding	1	1
Cough	1	1
Neurogenic Shock	1	1
Unspecified Respiratory Problem	1	1
Swelling/ Edema	1	1