TPLC - Total Product Life Cycle

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Device	ventilator, emergency, manual (resuscitator)
Regulation Description	Manual emergency ventilator.
Product Code	BTM
Regulation Number	868.5915
Device Class	2

Premarket Reviews
Manufacturer	Decision
ARCHEON
	SUBSTANTIALLY EQUIVALENT	1
1. K221841 EOlife®
COMPACT MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
LAERDAL MEDICAL AS
	SUBSTANTIALLY EQUIVALENT	1
SAFE BVM CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
XIAMEN COMPOWER MEDICAL TECH. CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Inflation Problem	15	15
Material Integrity Problem	12	12
Defective Component	11	11
Break	10	10
Device Damaged Prior to Use	9	9
Gas/Air Leak	9	9
Deflation Problem	8	8
Pressure Problem	8	8
Material Fragmentation	7	7
Unintended Deflation	5	5
Disconnection	5	5
Loose or Intermittent Connection	4	4
Mechanical Problem	4	4
Defective Device	4	4
Failure to Deliver	4	4
Crack	4	4
Incomplete or Inadequate Connection	4	4
Infusion or Flow Problem	4	4
No Flow	4	4
Material Split, Cut or Torn	4	4
Failure to Seal	3	3
Difficult to Open or Close	3	3
Device Reprocessing Problem	2	2
Obstruction of Flow	2	2
Incomplete or Missing Packaging	2	2
Component Missing	2	2
Use of Device Problem	2	2
Physical Resistance/Sticking	2	2
Device Handling Problem	2	2
Insufficient Device Problem Information	2	2
Output Problem	2	2
Device Dislodged or Dislocated	2	2
Detachment of Device or Device Component	2	2
Blocked Connection	2	2
Material Puncture/Hole	2	2
Decrease in Pressure	2	2
No Device Output	2	2
Failure to Deliver Energy	1	1
Fluid/Blood Leak	1	1
Fracture	1	1
Contamination	1	1
Suction Failure	1	1
Premature Separation	1	1
Complete Blockage	1	1
Missing Information	1	1
Imprecise or Erratic Results	1	1
Partial Blockage	1	1
Device Alarm System	1	1
Structural Problem	1	1
Tear, Rip or Hole in Device Packaging	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	92	95
Insufficient Information	36	40
No Known Impact Or Consequence To Patient	36	50
Low Oxygen Saturation	28	28
Cardiac Arrest	18	18
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	16	16
Decreased Level of Consciousness	16	16
No Consequences Or Impact To Patient	15	15
No Patient Involvement	10	10
Hypoxia	6	6
Decreased Respiratory Rate	5	5
Respiratory Insufficiency	5	5
Death	4	4
Respiratory Failure	3	3
Unspecified Respiratory Problem	3	3
Hypoventilation	3	3
Bradycardia	3	3
Loss of consciousness	3	3
Cerebral Edema	2	2
Vomiting	2	2
Respiratory Arrest	2	2
Low Blood Pressure/ Hypotension	2	2
Respiratory Distress Syndrome of Newborns	2	2
Overinflation of Lung	2	2
No Code Available	2	2
No Information	1	1
Anemia	1	1
Pneumothorax	1	1
Endocarditis	1	1
Dyspnea	1	1
Respiratory Distress	1	1
Missing Value Reason	1	1
Asystole	1	1
Cardiovascular Dysfunction/Insufficiency	1	1
Failure of Implant	1	1
Diminished Pulse Pressure	1	1
Foreign Body In Patient	1	1
Unspecified Tissue Injury	1	1