TPLC - Total Product Life Cycle

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Device	mattress, air flotation, alternating pressure
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	269	269
Insufficient Information	103	103
Deflation Problem	75	75
Inflation Problem	49	49
Use of Device Problem	40	40
Sparking	31	31
Dent in Material	21	21
Decrease in Pressure	20	20
Increase in Pressure	20	20
Electrical /Electronic Property Problem	18	18
Appropriate Term/Code Not Available	18	18
Device Operates Differently Than Expected	15	15
No Apparent Adverse Event	14	14
Unintended Deflation	13	13
Electrical Shorting	13	13
Fire	13	13
Thermal Decomposition of Device	12	12
Patient-Device Incompatibility	12	12
Device Inoperable	12	12
Failure to Power Up	11	11
Air Leak	11	11
Pressure Problem	9	9
Improper or Incorrect Procedure or Method	9	9
No Pressure	9	9
Device Handling Problem	8	8
Device Slipped	8	8
Break	8	8
Infusion or Flow Problem	8	8
Detachment of Device or Device Component	8	8
Unintended Electrical Shock	7	7
Product Quality Problem	7	7
Computer Software Problem	6	6
Human Factors Issue	6	6
Installation-Related Problem	6	6
Improper Flow or Infusion	6	6
Smoking	6	6
No Audible Alarm	6	6
Unclear Information	5	5
Material Separation	5	5
Material Integrity Problem	5	5
Component Falling	4	4
Moisture Damage	4	4
Inadequate or Insufficient Training	4	4
Mechanical Problem	4	4
Malposition of Device	4	4
Patient Device Interaction Problem	4	4
Difficult or Delayed Positioning	4	4
Structural Problem	3	3
Bent	3	3
Material Puncture/Hole	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Fall	326	326
Pressure Sores	161	161
No Clinical Signs, Symptoms or Conditions	103	103
No Consequences Or Impact To Patient	87	87
No Known Impact Or Consequence To Patient	52	52
Tissue Breakdown	33	33
Death	26	27
Pain	26	26
Insufficient Information	25	25
Injury	24	24
Bruise/Contusion	20	20
Skin Tears	20	20
Ulcer	18	18
Electric Shock	17	17
Bone Fracture(s)	17	17
No Information	16	16
No Patient Involvement	15	15
Physical Entrapment	13	14
Laceration(s)	12	12
Head Injury	10	10
Burn(s)	9	9
Hematoma	8	8
Discomfort	7	7
Hip Fracture	6	6
Contusion	6	6
Abrasion	5	5
Localized Skin Lesion	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Tissue Damage	4	4
Pleural Effusion	4	4
Skin Erosion	4	4
Joint Dislocation	3	3
Ulceration	3	3
Blister	3	3
Vertebral Fracture	2	2
Swelling/ Edema	2	2
Exposure to Body Fluids	2	2
Skin Discoloration	2	2
Skull Fracture	2	2
Fungal Infection	2	2
No Code Available	2	2
Skin Infection	2	2
Impaired Healing	2	2
Neck Pain	1	1
Strangulation	1	1
Cardiac Arrest	1	1
Local Reaction	1	1
Burn, Thermal	1	1
Swelling	1	1
Multiple Fractures	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	American National Mfg Inc	II	Aug-19-2016
2	Encompass Therapeutic Support Systems dba BG North America	II	Mar-31-2010
3	Getinge (Suzhou) Co Ltd	II	Jun-04-2021
4	Hill-Rom Manufacturing, Inc.	II	Jan-07-2009
5	SCM True Air Technologies LLC	II	May-19-2014
6	Stryker Medical Division of Stryker Corporation	II	Mar-08-2016