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
Insufficient Information	94	94
Adverse Event Without Identified Device or Use Problem	85	85
Increase in Pressure	76	76
Deflation Problem	59	59
Sparking	43	43
Use of Device Problem	27	27
Inflation Problem	25	25
Dent in Material	23	23
Gas/Air Leak	21	21
Appropriate Term/Code Not Available	19	19
Melted	16	16
No Apparent Adverse Event	15	15
Smoking	15	15
Decrease in Pressure	14	14
Unintended Deflation	14	14
Infusion or Flow Problem	12	12
Electrical Shorting	11	11
Unintended Electrical Shock	10	10
Patient-Device Incompatibility	9	9
Decreased Pump Speed	9	9
Electrical /Electronic Property Problem	8	8
Pressure Problem	8	8
Fire	7	7
Material Too Soft/Flexible	6	6
Detachment of Device or Device Component	5	5
Device Slipped	4	4
Mechanical Problem	4	4
Malposition of Device	4	4
Protective Measures Problem	4	4
Difficult or Delayed Positioning	4	4
Material Too Rigid or Stiff	3	3
Product Quality Problem	3	3
Therapeutic or Diagnostic Output Failure	3	3
Defective Component	3	3
Device Alarm System	3	3
Material Split, Cut or Torn	3	3
Inadequacy of Device Shape and/or Size	2	2
Sharp Edges	2	2
Installation-Related Problem	2	2
Complete Loss of Power	2	2
Self-Activation or Keying	2	2
Temperature Problem	2	2
Circuit Failure	2	2
Disconnection	2	2
No Pressure	2	2
Device-Device Incompatibility	2	2
Patient Device Interaction Problem	2	2
Contamination /Decontamination Problem	2	2
Break	2	2
Material Puncture/Hole	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	325	325
Fall	146	146
Pressure Sores	141	141
Insufficient Information	41	41
Tissue Breakdown	33	33
Ulcer	16	16
Skin Tears	15	15
Pain	15	15
Electric Shock	11	11
Bone Fracture(s)	10	10
Bruise/Contusion	8	8
Physical Entrapment	8	8
Head Injury	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Joint Dislocation	4	4
Limb Fracture	4	4
Laceration(s)	4	4
Localized Skin Lesion	4	4
Skin Inflammation/ Irritation	3	3
Skin Erosion	3	3
Burn(s)	3	3
Vertebral Fracture	2	2
Swelling/ Edema	2	2
Unspecified Tissue Injury	2	2
Skin Discoloration	2	2
Blister	2	2
Hematoma	2	2
Skull Fracture	2	2
Fungal Infection	2	2
Skin Infection	2	2
Rash	1	1
Post Traumatic Wound Infection	1	1
Neck Pain	1	1
Erythema	1	1
Strangulation	1	1
Discomfort	1	1
Numbness	1	1
Abrasion	1	1
Multiple Fractures	1	1
Pneumonia	1	1
Contact Dermatitis	1	1
Fatigue	1	1
Acoustic Shock	1	1
Hip Fracture	1	1
Headache	1	1
Superficial (First Degree) Burn	1	1
Impaired Healing	1	1
Unspecified Infection	1	1
External Prosthetic Device Pain	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Agiliti Health - Ellis	II	Feb-26-2026
2	Getinge (Suzhou) Co Ltd	II	Jun-04-2021
3	Stryker Medical Division of Stryker Corporation	II	Dec-11-2025
4	Turncare, Inc	II	Jun-12-2025
5	Turncare, Inc	II	Jun-12-2025