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	91	91
Adverse Event Without Identified Device or Use Problem	83	83
Increase in Pressure	72	72
Deflation Problem	54	54
Sparking	42	42
Use of Device Problem	25	25
Inflation Problem	24	24
Dent in Material	23	23
Appropriate Term/Code Not Available	19	19
Melted	14	14
Smoking	14	14
Unintended Deflation	13	13
No Apparent Adverse Event	12	12
Infusion or Flow Problem	11	11
Electrical Shorting	10	10
Unintended Electrical Shock	9	9
Patient-Device Incompatibility	9	9
Electrical /Electronic Property Problem	8	8
Pressure Problem	7	7
Fire	7	7
Gas/Air Leak	6	6
Device Slipped	4	4
Malposition of Device	4	4
Detachment of Device or Device Component	4	4
Difficult or Delayed Positioning	4	4
Material Split, Cut or Torn	3	3
Mechanical Problem	3	3
Device Alarm System	3	3
Protective Measures Problem	3	3
Defective Component	3	3
Product Quality Problem	3	3
Decrease in Pressure	3	3
Material Too Rigid or Stiff	3	3
Temperature Problem	2	2
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
Circuit Failure	2	2
Disconnection	2	2
No Pressure	2	2
Patient Device Interaction Problem	2	2
Contamination /Decontamination Problem	2	2
Device-Device Incompatibility	2	2
Therapeutic or Diagnostic Output Failure	2	2
Break	2	2
Noise, Audible	1	1
Failure to Run on Battery	1	1
Loss of or Failure to Bond	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	293	293
Fall	142	142
Pressure Sores	130	130
Insufficient Information	41	41
Tissue Breakdown	33	33
Ulcer	16	16
Skin Tears	15	15
Pain	15	15
Electric Shock	10	10
Bone Fracture(s)	10	10
Bruise/Contusion	8	8
Physical Entrapment	8	8
Head Injury	6	6
Laceration(s)	4	4
Localized Skin Lesion	4	4
Joint Dislocation	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Skin Inflammation/ Irritation	3	3
Skin Erosion	3	3
Burn(s)	3	3
Hematoma	2	2
Skull Fracture	2	2
Blister	2	2
Skin Discoloration	2	2
Fungal Infection	2	2
Limb Fracture	2	2
Swelling/ Edema	2	2
Vertebral Fracture	2	2
Skin Infection	2	2
Multiple Fractures	1	1
Abrasion	1	1
Post Traumatic Wound Infection	1	1
Neck Pain	1	1
Rash	1	1
Acoustic Shock	1	1
Discomfort	1	1
Erythema	1	1
Strangulation	1	1
Numbness	1	1
Fatigue	1	1
Hip Fracture	1	1
Pneumonia	1	1
Contact Dermatitis	1	1
Unspecified Tissue Injury	1	1
Unspecified Infection	1	1
Impaired Healing	1	1
Superficial (First Degree) Burn	1	1
Headache	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