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
Leak/Splash	2	2
Output Problem	2	2
Material Puncture/Hole	2	2
Smoking	2	2
No Audible Alarm	2	2
Thermal Decomposition of Device	2	2
Unintended System Motion	2	2
Device-Device Incompatibility	1	1
Unexpected Shutdown	1	1
Mechanical Problem	1	1
Unintended Electrical Shock	1	1
Defective Component	1	1
Deflation Problem	1	1
Failure to Deliver	1	1
Use of Device Problem	1	1
Flare or Flash	1	1
Decrease in Pressure	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Environmental Compatibility Problem	1	1
Device Emits Odor	1	1
Material Separation	1	1
Defective Alarm	1	1
Overheating of Device	1	1
Noise, Audible	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
No Known Impact Or Consequence To Patient	2	2
Unspecified Tissue Injury	2	2
Electric Shock	1	1
Foreign Body In Patient	1	1
Fall	1	1
No Consequences Or Impact To Patient	1	1