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
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
Material Split, Cut or Torn	29	29
Activation Problem	19	19
Unintended Movement	14	14
Sparking	10	10
Device Slipped	9	9
Electrical Power Problem	8	8
Appropriate Term/Code Not Available	3	3
Material Frayed	3	3
Melted	3	3
Unintended System Motion	2	2
Leak/Splash	2	2
No Audible Alarm	2	2
Smoking	2	2
Material Puncture/Hole	2	2
Output Problem	2	2
Electrical Shorting	2	2
Environmental Compatibility Problem	1	1
Flare or Flash	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Defective Alarm	1	1
Noise, Audible	1	1
Unintended Electrical Shock	1	1
Unexpected Shutdown	1	1
Material Separation	1	1
Device-Device Incompatibility	1	1
Use of Device Problem	1	1
Defective Component	1	1
Failure to Deliver	1	1
Arcing	1	1
Thermal Decomposition of Device	1	1
Deflation Problem	1	1
Mechanical Problem	1	1
Overheating of Device	1	1
Decrease in Pressure	1	1
Device Emits Odor	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	90	90
No Patient Involvement	13	13
Insufficient Information	6	6
Pressure Sores	4	4
No Known Impact Or Consequence To Patient	2	2
Unspecified Tissue Injury	2	2
Foreign Body In Patient	1	1
Electric Shock	1	1
Fall	1	1
No Consequences Or Impact To Patient	1	1