TPLC - Total Product Life Cycle

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Device	critical care ventilator
Definition	A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas during emergency and/or transfer use. Device is intended to be used temporarily and/or in emergency situations during declared public health emergency.
Product Code	QOV
Device Class	Not Classified

Device Problems	MDRs with this Device Problem	Events in those MDRs
Failure to Deliver	29	29
Gas Output Problem	27	29
Decrease in Pressure	23	25
Reset Problem	11	12
Unexpected Shutdown	10	10
Complete Loss of Power	9	9
Use of Device Problem	8	8
Intermittent Communication Failure	5	7
Adverse Event Without Identified Device or Use Problem	4	4
No Apparent Adverse Event	4	4
Obstruction of Flow	4	4
Device Difficult to Program or Calibrate	4	4
Circuit Failure	3	3
Complete Blockage	3	3
No Display/Image	3	3
No Flow	3	3
Mechanical Problem	3	3
Display or Visual Feedback Problem	2	2
Erratic Results	2	2
Failure to Sense	2	2
Inaccurate Flow Rate	1	1
Misassembly by Users	1	1
Insufficient Information	1	1
Data Problem	1	1
Device Handling Problem	1	1
Misassembled During Installation	1	1
Unexpected Therapeutic Results	1	1
Improper or Incorrect Procedure or Method	1	1
Insufficient Flow or Under Infusion	1	1
Difficult or Delayed Activation	1	1
Detachment of Device or Device Component	1	1
Gas/Air Leak	1	1
Human-Device Interface Problem	1	1
Infusion or Flow Problem	1	1
No Device Output	1	1
Off-Label Use	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	35	37
Insufficient Information	9	9
Low Oxygen Saturation	6	6
Cardiac Arrest	4	4
Respiratory Arrest	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Cough	1	1
Bronchospasm	1	1
Increased Respiratory Rate	1	1
Hypoxia	1	1