TPLC - Total Product Life Cycle

show TPLC since

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	111	111
Insufficient Information	95	95
Increase in Pressure	76	76
Deflation Problem	70	70
Sparking	44	44
Use of Device Problem	30	30
Inflation Problem	27	27
Dent in Material	23	23
Gas/Air Leak	21	21
Appropriate Term/Code Not Available	19	19
Smoking	16	16
Melted	16	16
Unintended Deflation	15	15
No Apparent Adverse Event	15	15
Decrease in Pressure	14	14
Electrical Shorting	14	14
Infusion or Flow Problem	12	12
Electrical /Electronic Property Problem	11	11
Unintended Electrical Shock	11	11
Patient-Device Incompatibility	11	11
Decreased Pump Speed	9	9
Fire	8	8
Pressure Problem	8	8
Detachment of Device or Device Component	7	7
Material Too Soft/Flexible	6	6
Mechanical Problem	5	5
Patient Device Interaction Problem	5	5
Protective Measures Problem	4	4
Malposition of Device	4	4
Difficult or Delayed Positioning	4	4
Device Slipped	4	4
Device Alarm System	3	3
Defective Component	3	3
Therapeutic or Diagnostic Output Failure	3	3
Product Quality Problem	3	3
Material Too Rigid or Stiff	3	3
Material Split, Cut or Torn	3	3
Installation-Related Problem	2	2
Inadequacy of Device Shape and/or Size	2	2
Sharp Edges	2	2
Complete Loss of Power	2	2
Self-Activation or Keying	2	2
Temperature Problem	2	2
Thermal Decomposition of Device	2	2
Circuit Failure	2	2
Disconnection	2	2
No Pressure	2	2
Contamination /Decontamination Problem	2	2
Device-Device Incompatibility	2	2
Break	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	327	327
Fall	166	166
Pressure Sores	148	148
Insufficient Information	42	42
Tissue Breakdown	34	34
Ulcer	16	16
Skin Tears	15	15
Pain	15	15
Electric Shock	12	12
No Consequences Or Impact To Patient	11	11
Bone Fracture(s)	10	10
Bruise/Contusion	8	8
Head Injury	8	8
Physical Entrapment	8	8
Laceration(s)	6	6
Localized Skin Lesion	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Joint Dislocation	4	4
Abrasion	4	4
Skin Erosion	4	4
Limb Fracture	4	4
Pleural Effusion	4	4
Skin Inflammation/ Irritation	3	3
Hematoma	3	3
Blister	3	3
Burn(s)	3	3
Vertebral Fracture	2	2
Skin Infection	2	2
Fungal Infection	2	2
Skull Fracture	2	2
Skin Discoloration	2	2
Swelling/ Edema	2	2
Unspecified Tissue Injury	2	2
Injury	2	2
No Patient Involvement	2	2
External Prosthetic Device Pain	1	1
Headache	1	1
Contact Dermatitis	1	1
Pneumonia	1	1
Numbness	1	1
Discomfort	1	1
Swelling	1	1
Strangulation	1	1
Erythema	1	1
Neck Pain	1	1
Rash	1	1
No Known Impact Or Consequence To Patient	1	1
Post Traumatic Wound Infection	1	1
Contusion	1	1
Multiple Fractures	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