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	109	109
Insufficient Information	92	92
Increase in Pressure	72	72
Deflation Problem	65	65
Sparking	43	43
Use of Device Problem	28	28
Inflation Problem	26	26
Dent in Material	23	23
Appropriate Term/Code Not Available	19	19
Smoking	15	15
Unintended Deflation	14	14
Electrical Shorting	13	13
Melted	12	12
No Apparent Adverse Event	12	12
Electrical /Electronic Property Problem	11	11
Infusion or Flow Problem	11	11
Patient-Device Incompatibility	11	11
Unintended Electrical Shock	10	10
Fire	8	8
Pressure Problem	7	7
Detachment of Device or Device Component	6	6
Gas/Air Leak	6	6
Patient Device Interaction Problem	5	5
Malposition of Device	4	4
Mechanical Problem	4	4
Device Slipped	4	4
Difficult or Delayed Positioning	4	4
Protective Measures Problem	3	3
Material Split, Cut or Torn	3	3
Defective Component	3	3
Decrease in Pressure	3	3
Device Alarm System	3	3
Product Quality Problem	3	3
Therapeutic or Diagnostic Output Failure	2	2
Temperature Problem	2	2
No Pressure	2	2
Sharp Edges	2	2
Disconnection	2	2
Complete Loss of Power	2	2
Circuit Failure	2	2
Thermal Decomposition of Device	2	2
Break	2	2
Installation-Related Problem	2	2
Device-Device Incompatibility	2	2
Contamination /Decontamination Problem	2	2
Inadequacy of Device Shape and/or Size	2	2
Self-Activation or Keying	2	2
Material Too Rigid or Stiff	2	2
Material Puncture/Hole	1	1
Decreased Pump Speed	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	292	292
Fall	162	162
Pressure Sores	137	137
Insufficient Information	42	42
Tissue Breakdown	34	34
Ulcer	16	16
Skin Tears	15	15
Pain	15	15
No Consequences Or Impact To Patient	11	11
Electric Shock	11	11
Bone Fracture(s)	9	9
Bruise/Contusion	8	8
Physical Entrapment	8	8
Head Injury	8	8
Laceration(s)	6	6
Localized Skin Lesion	5	5
Pleural Effusion	4	4
Skin Erosion	4	4
Abrasion	4	4
Joint Dislocation	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Blister	3	3
Hematoma	3	3
Burn(s)	3	3
Skin Inflammation/ Irritation	3	3
Skin Discoloration	2	2
Injury	2	2
No Patient Involvement	2	2
Skull Fracture	2	2
Fungal Infection	2	2
Limb Fracture	2	2
Swelling/ Edema	2	2
Skin Infection	2	2
Vertebral Fracture	2	2
Multiple Fractures	1	1
No Known Impact Or Consequence To Patient	1	1
Contusion	1	1
Post Traumatic Wound Infection	1	1
Neck Pain	1	1
Rash	1	1
Swelling	1	1
Discomfort	1	1
Erythema	1	1
Strangulation	1	1
Numbness	1	1
Acoustic Shock	1	1
Fatigue	1	1
Hip Fracture	1	1
Pneumonia	1	1
Contact Dermatitis	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Getinge (Suzhou) Co Ltd	II	Jun-04-2021
2	Stryker Medical Division of Stryker Corporation	II	Dec-11-2025
3	Turncare, Inc	II	Jun-12-2025
4	Turncare, Inc	II	Jun-12-2025