TPLC - Total Product Life Cycle

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Device	mattress, air flotation, alternating pressure
Regulation Description	Alternating pressure air flotation mattress.
Product Code	FNM
Regulation Number	880.5550
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	97	97
Insufficient Information	83	83
Deflation Problem	59	59
Increase in Pressure	44	44
Sparking	35	35
Dent in Material	23	23
Use of Device Problem	21	21
Appropriate Term/Code Not Available	19	19
Inflation Problem	17	17
Unintended Deflation	13	13
Electrical Shorting	12	12
No Apparent Adverse Event	11	11
Patient-Device Incompatibility	11	11
Electrical /Electronic Property Problem	10	10
Melted	10	10
Smoking	10	10
Infusion or Flow Problem	10	10
Unintended Electrical Shock	9	9
Pressure Problem	6	6
Fire	6	6
Detachment of Device or Device Component	6	6
Patient Device Interaction Problem	5	5
Device Slipped	4	4
Mechanical Problem	4	4
Malposition of Device	4	4
Difficult or Delayed Positioning	4	4
Material Split, Cut or Torn	3	3
Protective Measures Problem	3	3
Defective Component	3	3
Product Quality Problem	3	3
Gas/Air Leak	3	3
Self-Activation or Keying	2	2
Complete Loss of Power	2	2
Installation-Related Problem	2	2
Inadequacy of Device Shape and/or Size	2	2
Sharp Edges	2	2
Decrease in Pressure	2	2
Thermal Decomposition of Device	2	2
Material Too Rigid or Stiff	2	2
No Pressure	2	2
Contamination /Decontamination Problem	2	2
Therapeutic or Diagnostic Output Failure	2	2
Device-Device Incompatibility	2	2
Disconnection	2	2
Circuit Failure	2	2
Flare or Flash	1	1
Improper Flow or Infusion	1	1
Material Twisted/Bent	1	1
Obstruction of Flow	1	1
Excess Flow or Over-Infusion	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	245	245
Fall	159	159
Pressure Sores	111	111
Insufficient Information	37	37
Tissue Breakdown	33	33
Ulcer	16	16
Skin Tears	15	15
Pain	14	14
No Consequences Or Impact To Patient	11	11
Electric Shock	11	11
Bruise/Contusion	8	8
Bone Fracture(s)	7	7
Head Injury	7	7
Physical Entrapment	6	6
Laceration(s)	6	6
Localized Skin Lesion	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Joint Dislocation	4	4
Pleural Effusion	4	4
Abrasion	4	4
Skin Erosion	4	4
Burn(s)	3	3
Blister	3	3
Hematoma	3	3
Skin Discoloration	2	2
Injury	2	2
No Patient Involvement	2	2
Skull Fracture	2	2
Fungal Infection	2	2
Swelling/ Edema	2	2
Skin Infection	2	2
Vertebral Fracture	2	2
Post Traumatic Wound Infection	1	1
No Known Impact Or Consequence To Patient	1	1
Contusion	1	1
Neck Pain	1	1
Multiple Fractures	1	1
Swelling	1	1
Discomfort	1	1
Skin Inflammation/ Irritation	1	1
Pneumonia	1	1
Fatigue	1	1
Limb Fracture	1	1
Contact Dermatitis	1	1
Unspecified Tissue Injury	1	1
Acoustic Shock	1	1
Hip Fracture	1	1
Headache	1	1
Superficial (First Degree) Burn	1	1
Impaired Healing	1	1