TPLC - Total Product Life Cycle

• Device: bed, air fluidized
• Product Code: INX
• Regulation Number: 890.5160
• Device Class: 2

MDR Year	MDR Reports	MDR Events
2014	282	282
2015	51	51
2016	10	10
2017	28	28
2018	22	22
2019	15	15
2020	2	2
2021	2	2
2022	18	18
2023	60	60
2024	23	23

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Slipped	256	256
Material Split, Cut or Torn	29	29
Mechanical Problem	28	28
Device Operates Differently Than Expected	22	22
Unintended Movement	21	21
Activation Problem	19	19
Device Inoperable	14	14
Adverse Event Without Identified Device or Use Problem	13	13
Sparking	12	12
Device Displays Incorrect Message	10	10
Leak/Splash	9	9
Insufficient Information	8	8
Electrical Power Problem	8	8
Use of Device Problem	7	7
Device Alarm System	6	6
Break	6	6
Loss of Power	5	5
Smoking	5	5
Device Emits Odor	4	4
Unintended System Motion	4	4
Overheating of Device	3	3
Loose or Intermittent Connection	3	3
Melted	3	3
Fire	3	3
Material Frayed	3	3
Defective Component	3	3
Inflation Problem	3	3
Appropriate Term/Code Not Available	3	3
Noise, Audible	3	3
Output Problem	2	2
Mechanics Altered	2	2
Electrical Shorting	2	2
Improper Flow or Infusion	2	2
Improper or Incorrect Procedure or Method	2	2
Unexpected Therapeutic Results	2	2
Unintended Head Motion	2	2
Thermal Decomposition of Device	2	2
Display or Visual Feedback Problem	2	2
No Audible Alarm	2	2
Bent	2	2
Collapse	2	2
Detachment Of Device Component	2	2
Material Puncture/Hole	2	2
Self-Activation or Keying	2	2
Fail-Safe Design Failure	2	2
Pressure Problem	2	2
Temperature Problem	1	1
Torn Material	1	1
Unintended Electrical Shock	1	1
Unexpected Shutdown	1	1
Air Leak	1	1
Particulates	1	1
Difficult To Position	1	1
Material Separation	1	1
Material Rupture	1	1
Decrease in Pressure	1	1
Component Falling	1	1
Crack	1	1
Application Interface Becomes Non-Functional Or Program Exits Abnormally	1	1
Deflation Problem	1	1
Defective Alarm	1	1
Electromagnetic Interference	1	1
Electrical /Electronic Property Problem	1	1
Circuit Failure	1	1
Hole In Material	1	1
Inadequate or Insufficient Training	1	1
Sticking	1	1
Component Missing	1	1
Failure to Deliver	1	1
Device Issue	1	1
Malfunction	1	1
Arcing	1	1
Defective Device	1	1
Ambient Temperature Problem	1	1
Device-Device Incompatibility	1	1
Incorrect Device Or Component Shipped	1	1
Lack of Maintenance Documentation or Guidelines	1	1
Material Protrusion/Extrusion	1	1
Electronic Property Issue	1	1
Environmental Compatibility Problem	1	1
Flare or Flash	1	1
Device Contamination with Chemical or Other Material	1	1
Human-Device Interface Problem	1	1
Moisture or Humidity Problem	1	1
Naturally Worn	1	1
Positioning Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	217	217
No Consequences Or Impact To Patient	102	102
No Clinical Signs, Symptoms or Conditions	90	90
Pressure Sores	31	31
No Patient Involvement	18	18
Injury	14	14
Fall	11	11
Therapeutic Response, Decreased	6	6
Insufficient Information	6	6
No Information	5	5
Pain	4	4
Death	3	3
Skin Erosion	2	2
Therapeutic Effects, Unexpected	2	2
Abrasion	2	2
Impaired Healing	2	2
Electric Shock	2	2
Unspecified Tissue Injury	2	2
Skin Tears	1	1
Discomfort	1	1
No Code Available	1	1
Tissue Breakdown	1	1
Foreign Body In Patient	1	1
Burn(s)	1	1
Crushing Injury	1	1
Shock	1	1
Bone Fracture(s)	1	1
Incontinence	1	1
Laceration(s)	1	1
Myocardial Infarction	1	1
Necrosis	1	1
Tissue Damage	1	1
Concussion	1	1
Swelling	1	1
Brain Injury	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Hill-Rom Manufacturing, Inc.	II	Aug-25-2009
2	Hill-Rom, Inc.	III	Mar-01-2012