TPLC - Total Product Life Cycle

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

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
Disconnection	11	11
Gas/Air Leak	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
Occlusion Within Device	3	3
Loss of or Failure to Bond	3	3
Detachment Of Device Component	3	3
Defective Component	3	3
Failure to Deliver	3	3
Detachment of Device or Device Component	3	3
Cut In Material	2	2
Device Damaged Prior to Use	2	2
Disassembly	2	2
Thermal Decomposition of Device	2	2
Mechanical Problem	2	2
Human-Device Interface Problem	2	2
Device Dislodged or Dislocated	2	2
Device Contamination with Chemical or Other Material	2	2
Temperature Problem	2	2
Torn Material	1	1
Key or Button Unresponsive/not Working	1	1
Material Integrity Problem	1	1
No Fail-Safe Mechanism	1	1
Output Problem	1	1
Unintended Ejection	1	1
Material Fragmentation	1	1
Material Rupture	1	1
Circuit Failure	1	1
Device Alarm System	1	1
Alarm Not Visible	1	1
Suction Problem	1	1
Failure to Align	1	1
Device Operates Differently Than Expected	1	1
Delivery System Failure	1	1
Device Displays Incorrect Message	1	1
Ambient Noise Problem	1	1
Communication or Transmission 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	37	37
No Known Impact Or Consequence To Patient	19	19
Insufficient Information	8	8
Low Oxygen Saturation	3	3
No Information	2	2
No Code Available	2	2
Death	1	1
Anxiety	1	1