TPLC - Total Product Life Cycle

• Device: mattress, air flotation, alternating pressure
• Product Code: FNM
• Regulation Number: 880.5550
• Device Class: 2

MDR Year	MDR Reports	MDR Events
2019	101	101
2020	58	58
2021	47	47
2022	75	75
2023	197	197
2024	37	37

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	151	151
Insufficient Information	73	73
Deflation Problem	55	55
Dent in Material	21	21
Sparking	19	19
Use of Device Problem	18	18
Increase in Pressure	18	18
Appropriate Term/Code Not Available	17	17
Inflation Problem	16	16
Unintended Deflation	13	13
No Apparent Adverse Event	12	12
Patient-Device Incompatibility	11	11
Electrical /Electronic Property Problem	10	10
Electrical Shorting	10	10
Detachment of Device or Device Component	7	7
Infusion or Flow Problem	7	7
Unintended Electrical Shock	7	7
Fire	7	7
Pressure Problem	6	6
Decrease in Pressure	5	5
Device Slipped	5	5
Mechanical Problem	4	4
Patient Device Interaction Problem	4	4
Protective Measures Problem	3	3
Installation-Related Problem	3	3
No Pressure	3	3
Device-Device Incompatibility	3	3
Difficult or Delayed Positioning	3	3
Smoking	3	3
Product Quality Problem	3	3
Contamination /Decontamination Problem	2	2
Defective Component	2	2
Disconnection	2	2
Use of Incorrect Control/Treatment Settings	2	2
Thermal Decomposition of Device	2	2
Malposition of Device	2	2
Gas/Air Leak	2	2
Therapeutic or Diagnostic Output Failure	2	2
Sharp Edges	2	2
Complete Loss of Power	2	2
Inaccurate Information	1	1
Unclear Information	1	1
Device Fell	1	1
Component Misassembled	1	1
Material Split, Cut or Torn	1	1
Noise, Audible	1	1
Improper Flow or Infusion	1	1
Pumping Problem	1	1
Device Damaged by Another Device	1	1
Device Dislodged or Dislocated	1	1
Flare or Flash	1	1
Positioning Problem	1	1
Power Problem	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Material Protrusion/Extrusion	1	1
Material Twisted/Bent	1	1
Circuit Failure	1	1
Device Alarm System	1	1
Inability to Auto-Fill	1	1
Crack	1	1
Unintended System Motion	1	1
Energy Output Problem	1	1
Overheating of Device	1	1
Failure to Power Up	1	1
Loose or Intermittent Connection	1	1
Component Missing	1	1
Defective Device	1	1
Connection Problem	1	1
Activation, Positioning or Separation Problem	1	1
Material Too Rigid or Stiff	1	1
Self-Activation or Keying	1	1
Short Fill	1	1
Inadequacy of Device Shape and/or Size	1	1
Inadequate or Insufficient Training	1	1
Decreased Pump Speed	1	1
Material Puncture/Hole	1	1
Air/Gas in Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Fall	202	202
Pressure Sores	90	90
No Clinical Signs, Symptoms or Conditions	68	68
Tissue Breakdown	30	30
Insufficient Information	20	20
No Consequences Or Impact To Patient	16	16
Pain	15	15
Ulcer	14	14
Bruise/Contusion	11	11
Bone Fracture(s)	10	10
Electric Shock	9	9
Skin Tears	8	8
No Known Impact Or Consequence To Patient	7	7
Head Injury	7	7
Laceration(s)	7	7
Death	6	6
Physical Entrapment	5	5
Localized Skin Lesion	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Injury	4	4
Hematoma	4	4
Pleural Effusion	4	4
Skin Erosion	4	4
Abrasion	4	4
Burn(s)	3	3
No Patient Involvement	3	3
Blister	3	3
Swelling/ Edema	2	2
Vertebral Fracture	2	2
Skin Infection	2	2
Joint Dislocation	2	2
Fungal Infection	2	2
Skull Fracture	2	2
Skin Discoloration	2	2
Swelling	1	1
Pneumonia	1	1
Contusion	1	1
Acoustic Shock	1	1
Headache	1	1
Fatigue	1	1
Neck Pain	1	1
Impaired Healing	1	1
Discomfort	1	1
Superficial (First Degree) Burn	1	1
No Code Available	1	1
Limb Fracture	1	1
Multiple Fractures	1	1
Skin Inflammation/ Irritation	1	1
Contact Dermatitis	1	1
Unspecified Tissue Injury	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Getinge (Suzhou) Co Ltd	II	Jun-04-2021