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