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	173	173
Insufficient Information	84	84
Deflation Problem	65	65
Increase in Pressure	44	44
Sparking	35	35
Use of Device Problem	25	25
Dent in Material	23	23
Inflation Problem	21	21
Appropriate Term/Code Not Available	19	19
Unintended Deflation	13	13
No Apparent Adverse Event	12	12
Electrical Shorting	12	12
Electrical /Electronic Property Problem	11	11
Patient-Device Incompatibility	11	11
Smoking	11	11
Infusion or Flow Problem	10	10
Melted	10	10
Unintended Electrical Shock	9	9
Fire	8	8
Detachment of Device or Device Component	7	7
Pressure Problem	6	6
Device Slipped	5	5
Decrease in Pressure	5	5
Patient Device Interaction Problem	5	5
Difficult or Delayed Positioning	4	4
Malposition of Device	4	4
Mechanical Problem	4	4
Defective Component	3	3
Product Quality Problem	3	3
Installation-Related Problem	3	3
Protective Measures Problem	3	3
Material Split, Cut or Torn	3	3
No Pressure	3	3
Device-Device Incompatibility	3	3
Gas/Air Leak	3	3
Inadequacy of Device Shape and/or Size	2	2
Use of Incorrect Control/Treatment Settings	2	2
Sharp Edges	2	2
Thermal Decomposition of Device	2	2
Complete Loss of Power	2	2
Self-Activation or Keying	2	2
Circuit Failure	2	2
Disconnection	2	2
Material Too Rigid or Stiff	2	2
Contamination /Decontamination Problem	2	2
Therapeutic or Diagnostic Output Failure	2	2
Noise, Audible	1	1
Failure to Run on Battery	1	1
Loose or Intermittent Connection	1	1
Overheating of Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	245	245
Fall	220	220
Pressure Sores	128	128
Insufficient Information	37	37
Tissue Breakdown	34	34
No Consequences Or Impact To Patient	16	16
Skin Tears	16	16
Ulcer	16	16
Pain	15	15
Bruise/Contusion	11	11
Electric Shock	11	11
Bone Fracture(s)	10	10
Laceration(s)	7	7
Head Injury	7	7
No Known Impact Or Consequence To Patient	7	7
Death	6	6
Physical Entrapment	6	6
Localized Skin Lesion	5	5
Pleural Effusion	4	4
Injury	4	4
Skin Erosion	4	4
Abrasion	4	4
Hematoma	4	4
Joint Dislocation	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Blister	3	3
Burn(s)	3	3
No Patient Involvement	3	3
Skin Discoloration	2	2
Skull Fracture	2	2
Fungal Infection	2	2
Swelling/ Edema	2	2
Skin Infection	2	2
Vertebral Fracture	2	2
Contusion	1	1
Post Traumatic Wound Infection	1	1
Multiple Fractures	1	1
Skin Inflammation/ Irritation	1	1
Neck Pain	1	1
Swelling	1	1
Discomfort	1	1
No Code Available	1	1
Fatigue	1	1
Acoustic Shock	1	1
Pneumonia	1	1
Limb Fracture	1	1
Contact Dermatitis	1	1
Unspecified Tissue Injury	1	1
Hip Fracture	1	1
Headache	1	1