TPLC - Total Product Life Cycle

show TPLC since

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
Fire	4	4
No Audible Alarm	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
Gas Output Problem	2	2
Incorrect, Inadequate or Imprecise Result or Readings	2	2
Volume Accuracy Problem	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
Delayed Alarm	1	1
Material Frayed	1	1
Crack	1	1
Display or Visual Feedback Problem	1	1
Break	1	1
Insufficient Information	1	1
Device Damaged by Another Device	1	1
Improper Flow or Infusion	1	1
Failure to Align	1	1
Loose or Intermittent Connection	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	58	58
Low Oxygen Saturation	14	14
No Patient Involvement	12	12
No Consequences Or Impact To Patient	7	7
Insufficient Information	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