TPLC - Total Product Life Cycle

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Device	mixer, breathing gases, anesthesia inhalation
Product Code	BZR
Regulation Number	868.5330
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Mechanical Problem	38	38
Leak/Splash	12	12
Output Problem	6	6
Therapeutic or Diagnostic Output Failure	4	4
No Apparent Adverse Event	4	4
Material Integrity Problem	4	4
Device Alarm System	4	4
No Audible Alarm	4	4
Fire	4	4
Gas Output Problem	3	3
Infusion or Flow Problem	3	3
No Flow	3	3
Inaccurate Delivery	3	3
Gas/Air Leak	3	3
Protective Measures Problem	3	3
Appropriate Term/Code Not Available	2	2
Defective Device	2	2
Medical Gas Supply Problem	2	2
Positioning Problem	2	2
Contamination	2	2
Incorrect, Inadequate or Imprecise Result or Readings	2	2
Volume Accuracy Problem	1	1
Improper or Incorrect Procedure or Method	1	1
No Audible Prompt/Feedback	1	1
Failure to Deliver	1	1
Melted	1	1
Misconnection	1	1
Output above Specifications	1	1
No Device Output	1	1
Crack	1	1
Display or Visual Feedback Problem	1	1
Break	1	1
Delayed Alarm	1	1
Material Frayed	1	1
Pressure Problem	1	1
Insufficient Information	1	1
Device Damaged by Another Device	1	1
Improper Flow or Infusion	1	1
High Readings	1	1
Failure to Align	1	1
Loose or Intermittent Connection	1	1
Device Handling Problem	1	1
Misassembly During Maintenance/Repair	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	67	67
Low Oxygen Saturation	15	15
No Patient Involvement	12	12
Insufficient Information	8	8
No Consequences Or Impact To Patient	7	7
No Known Impact Or Consequence To Patient	5	5
No Information	3	3
Superficial (First Degree) Burn	2	2
Death	1	1
Hypoxia	1	1
Retinal Injury	1	1
Respiratory Arrest	1	1