TPLC - Total Product Life Cycle

• Device: circulator, breathing-circuit
• Product Code: CAG
• Regulation Number: 868.5250
• Device Class: 2

MDR Year	MDR Reports	MDR Events
2014	95	95
2015	41	41
2016	2	2
2017	2	2
2018	2	2
2019	3	3
2020	4	4
2021	13	13
2022	9	9
2023	14	14
2024	3	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Leak/Splash	39	39
Melted	28	28
Break	18	18
Crack	15	15
Material Separation	13	13
Split	11	11
Gas/Air Leak	11	11
Disconnection	11	11
Hole In Material	11	11
Misassembled	9	9
Infusion or Flow Problem	7	7
Connection Problem	5	5
Fitting Problem	5	5
Device Inoperable	4	4
Material Puncture/Hole	4	4
Loss of or Failure to Bond	3	3
Detachment Of Device Component	3	3
Failure to Deliver	3	3
Occlusion Within Device	3	3
Defective Component	3	3
Detachment of Device or Device Component	3	3
Temperature Problem	2	2
Device Dislodged or Dislocated	2	2
Cut In Material	2	2
Mechanical Problem	2	2
Disassembly	2	2
Thermal Decomposition of Device	2	2
Human-Device Interface Problem	2	2
Device Damaged Prior to Use	2	2
Device Contamination with Chemical or Other Material	2	2
Device Displays Incorrect Message	1	1
Device Operates Differently Than Expected	1	1
No Fail-Safe Mechanism	1	1
Circuit Failure	1	1
Material Integrity Problem	1	1
Output Problem	1	1
Delivery System Failure	1	1
Communication or Transmission Problem	1	1
Key or Button Unresponsive/not Working	1	1
Alarm Not Visible	1	1
Material Fragmentation	1	1
Unintended Ejection	1	1
Failure to Align	1	1
Moisture or Humidity Problem	1	1
Material Rupture	1	1
Torn Material	1	1
Suction Problem	1	1
Device Alarm System	1	1
Ambient Noise Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	71	71
No Patient Involvement	63	63
No Clinical Signs, Symptoms or Conditions	38	38
No Known Impact Or Consequence To Patient	19	19
Insufficient Information	8	8
Low Oxygen Saturation	3	3
No Code Available	2	2
No Information	2	2
Death	1	1
Anxiety	1	1