TPLC - Total Product Life Cycle

• Device: bed, air fluidized
• Regulation Description: Air-fluidized bed.
• Product Code: INX
• Regulation Number: 890.5160
• Device Class: 2

MDR Year	MDR Reports	MDR Events
2016	10	10
2017	28	28
2018	22	22
2019	15	15
2020	2	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Brake	25	25
Device Slipped	19	19
Adverse Event Without Identified Device or Use Problem	8	8
Device Displays Incorrect Message	5	5
Device Operates Differently Than Expected	5	5
Insufficient Information	4	4
Unintended Movement	4	4
Device Inoperable	3	3
Leak/Splash	3	3
Unintended System Motion	3	3
Self-Activation or Keying	2	2
Device Alarm System	2	2
Fail-Safe Design Failure	2	2
Defective Component	2	2
Pressure Problem	2	2
Inflation Problem	2	2
Mechanical Problem	2	2
Fire	2	2
Loss of Power	2	2
Use of Device Problem	2	2
Failure to Deliver	1	1
Device Issue	1	1
Sparking	1	1
Manifold	1	1
Unintended Head Motion	1	1
Overheating of Device	1	1
Difficult To Position	1	1
Heads	1	1
Air Leak	1	1
Deflation Problem	1	1
Display or Visual Feedback Problem	1	1
Material Split, Cut or Torn	1	1
Smoking	1	1
Environmental Compatibility Problem	1	1
Human-Device Interface Problem	1	1
Improper Flow or Infusion	1	1
Temperature Problem	1	1
Torn Material	1	1
Improper or Incorrect Procedure or Method	1	1
Device-Device Incompatibility	1	1
Electronic Property Issue	1	1
Positioning Problem	1	1
Defective Alarm	1	1
Circuit Failure	1	1
Component Falling	1	1
Electrical /Electronic Property Problem	1	1
Alarm	1	1
Wire	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	23	23
No Patient Involvement	17	17
Pressure Sores	16	16
Injury	7	7
No Consequences Or Impact To Patient	4	4
Fall	2	2
Skin Erosion	2	2
Pain	2	2
No Information	2	2
No Code Available	1	1
Shock	1	1
Brain Injury	1	1
Bone Fracture(s)	1	1
Concussion	1	1
Crushing Injury	1	1