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
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	13	13
Material Integrity Problem	12	12
Gas/Air Leak	12	12
Break	10	10
Pressure Problem	8	8
Deflation Problem	8	8
Material Fragmentation	7	7
Unintended Deflation	5	5
Disconnection	4	4
Material Split, Cut or Torn	4	4
Loose or Intermittent Connection	4	4
Crack	4	4
Infusion or Flow Problem	4	4
Failure to Deliver	4	4
Failure to Seal	3	3
Mechanical Problem	3	3
No Flow	3	3
Incomplete or Inadequate Connection	3	3
Component Missing	3	3
Insufficient Device Problem Information	3	3
No Device Output	2	2
Fluid/Blood Leak	2	2
Device Reprocessing Problem	2	2
Device Dislodged or Dislocated	2	2
Detachment of Device or Device Component	2	2
Device Handling Problem	2	2
Material Deformation	2	2
Blocked Connection	2	2
Decrease in Pressure	2	2
Obstruction of Flow	2	2
Use of Device Problem	2	2
Defective Device	2	2
Defective Component	2	2
Material Puncture/Hole	2	2
Physical Resistance/Sticking	2	2
Output Problem	2	2
Incomplete or Missing Packaging	2	2
Improper Flow or Infusion	1	1
Imprecise or Erratic Results	1	1
Insufficient Flow or Under Infusion	1	1
Structural Problem	1	1
Material Too Rigid or Stiff	1	1
Contamination	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Ventilation Problem in Device Environment	1	1
Misassembled	1	1
Packaging Problem	1	1
Partial Blockage	1	1
Incorrect Measurement	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	96	99
Insufficient Information	39	43
Low Oxygen Saturation	25	25
Cardiac Arrest	20	20
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	16	16
Decreased Level of Consciousness	16	16
Hypoxia	9	9
Respiratory Insufficiency	5	5
Decreased Respiratory Rate	5	5
Unspecified Respiratory Problem	4	4
Bradycardia	3	3
Loss of consciousness	3	3
Respiratory Failure	3	3
Hypoventilation	2	2
Respiratory Arrest	2	2
Vomiting	2	2
Overinflation of Lung	2	2
Respiratory Distress Syndrome of Newborns	2	2
Low Blood Pressure/ Hypotension	2	2
Cerebral Edema	2	2
Pneumothorax	1	1
Failure of Implant	1	1
Cardiovascular Dysfunction/Insufficiency	1	1
Diminished Pulse Pressure	1	1
Anemia	1	1
Foreign Body In Patient	1	1
Dyspnea	1	1
Asystole	1	1
Unspecified Tissue Injury	1	1
Endocarditis	1	1