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
Device Difficult to Program or Calibrate	5	5
Intermittent Communication Failure	5	7
No Display/Image	4	4
Obstruction of Flow	4	4
Adverse Event Without Identified Device or Use Problem	4	4
No Apparent Adverse Event	4	4
Circuit Failure	3	3
Mechanical Problem	3	3
Complete Blockage	3	3
Display or Visual Feedback Problem	3	3
No Flow	3	3
Erratic Results	2	2
Failure to Sense	2	2
Off-Label Use	1	1
Insufficient Information	1	1
Misassembled During Installation	1	1
Difficult or Delayed Activation	1	1
Gas/Air Leak	1	1
Inaccurate Flow Rate	1	1
Insufficient Flow or Under Infusion	1	1
Infusion or Flow Problem	1	1
Misassembly by Users	1	1
Data Problem	1	1
Device Handling Problem	1	1
Detachment of Device or Device Component	1	1
Unexpected Therapeutic Results	1	1
Human-Device Interface Problem	1	1
Improper or Incorrect Procedure or Method	1	1
No Device Output	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	36	38
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
Increased Respiratory Rate	1	1
Bronchospasm	1	1
Cough	1	1
Hypoxia	1	1