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	43	43

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Split, Cut or Torn	34	34
Activation Problem	24	24
Unintended Movement	15	15
Sparking	14	14
Device Slipped	9	9
Electrical Power Problem	8	8
Material Frayed	5	5
Appropriate Term/Code Not Available	4	4
Electrical Shorting	3	3
Melted	3	3
Arcing	3	3
Thermal Decomposition of Device	2	2
Leak/Splash	2	2
Smoking	2	2
Unintended System Motion	2	2
Output Problem	2	2
No Audible Alarm	2	2
Material Puncture/Hole	2	2
Device Emits Odor	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Decrease in Pressure	1	1
Deflation Problem	1	1
Environmental Compatibility Problem	1	1
Defective Alarm	1	1
Defective Component	1	1
Use of Device Problem	1	1
Unexpected Shutdown	1	1
Overheating of Device	1	1
Flare or Flash	1	1
Noise, Audible	1	1
Material Separation	1	1
Mechanical Problem	1	1
Device-Device Incompatibility	1	1
Failure to Deliver	1	1
Unintended Electrical Shock	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	109	109
No Patient Involvement	13	13
Insufficient Information	6	6
Pressure Sores	5	5
Unspecified Tissue Injury	2	2
No Known Impact Or Consequence To Patient	2	2
Fall	1	1
No Consequences Or Impact To Patient	1	1
Electric Shock	1	1
Foreign Body In Patient	1	1