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	67	67
Sparking	43	43
Use of Device Problem	30	30
Inflation Problem	27	27
Dent in Material	23	23
Appropriate Term/Code Not Available	19	19
Smoking	16	16
Melted	16	16
No Apparent Adverse Event	15	15
Electrical Shorting	14	14
Unintended Deflation	14	14
Unintended Electrical Shock	11	11
Infusion or Flow Problem	11	11
Patient-Device Incompatibility	11	11
Electrical /Electronic Property Problem	11	11
Fire	8	8
Pressure Problem	8	8
Gas/Air Leak	7	7
Detachment of Device or Device Component	7	7
Material Too Soft/Flexible	6	6
Patient Device Interaction Problem	5	5
Mechanical Problem	5	5
Difficult or Delayed Positioning	4	4
Device Slipped	4	4
Malposition of Device	4	4
Therapeutic or Diagnostic Output Failure	3	3
Protective Measures Problem	3	3
Device Alarm System	3	3
Decrease in Pressure	3	3
Product Quality Problem	3	3
Material Too Rigid or Stiff	3	3
Defective Component	3	3
Material Split, Cut or Torn	3	3
Sharp Edges	2	2
Complete Loss of Power	2	2
Self-Activation or Keying	2	2
Inadequacy of Device Shape and/or Size	2	2
Disconnection	2	2
Break	2	2
Thermal Decomposition of Device	2	2
Circuit Failure	2	2
No Pressure	2	2
Temperature Problem	2	2
Contamination /Decontamination Problem	2	2
Installation-Related Problem	2	2
Device-Device Incompatibility	2	2
Device Dislodged or Dislocated	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	306	306
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
Limb Fracture	4	4
Abrasion	4	4
Skin Erosion	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
Swelling/ Edema	2	2
Unspecified Tissue Injury	2	2
No Patient Involvement	2	2
Injury	2	2
Skin Discoloration	2	2
Skull Fracture	2	2
Fungal Infection	2	2
Skin Infection	2	2
Erythema	1	1
Neck Pain	1	1
Strangulation	1	1
Swelling	1	1
Discomfort	1	1
Numbness	1	1
Rash	1	1
No Known Impact Or Consequence To Patient	1	1
Post Traumatic Wound Infection	1	1
Pneumonia	1	1
Contusion	1	1
Multiple Fractures	1	1
Contact Dermatitis	1	1
Fatigue	1	1
Acoustic Shock	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