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
Break	15	15
Gas/Air Leak	14	14
Inflation Problem	13	13
Material Integrity Problem	11	11
Deflation Problem	9	9
Pressure Problem	8	8
Detachment of Device or Device Component	7	7
Physical Resistance/Sticking	6	6
Crack	6	13
Defective Device	6	6
Failure to Deliver	6	6
No Flow	5	5
Material Fragmentation	5	5
Failure to Seal	4	4
Material Split, Cut or Torn	4	4
Incomplete or Inadequate Connection	4	4
Material Puncture/Hole	4	4
Unintended Deflation	4	4
Therapeutic or Diagnostic Output Failure	4	4
Component Missing	4	4
Infusion or Flow Problem	4	4
Fluid/Blood Leak	3	3
Mechanical Problem	3	3
Loose or Intermittent Connection	3	3
Output Problem	3	3
Use of Device Problem	3	3
Obstruction of Flow	3	3
No Device Output	2	2
Difficult to Open or Close	2	2
Connection Problem	2	2
Device Dislodged or Dislocated	2	2
Tear, Rip or Hole in Device Packaging	2	2
Inadequacy of Device Shape and/or Size	2	2
Device Handling Problem	2	2
Packaging Problem	2	2
Material Deformation	2	2
Blocked Connection	2	2
Structural Problem	2	2
Decrease in Pressure	2	2
Material Twisted/Bent	2	2
Improper Flow or Infusion	2	2
Material Too Rigid or Stiff	2	2
Defective Component	2	2
Insufficient Information	2	2
Incomplete or Missing Packaging	2	2
Disconnection	2	2
Insufficient Flow or Under Infusion	1	1
Misassembled	1	1
Contamination	1	1
Partial Blockage	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	81	84
Insufficient Information	33	37
Low Oxygen Saturation	23	23
Cardiac Arrest	17	17
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	16	16
Hypoxia	6	6
Respiratory Insufficiency	5	5
Decreased Respiratory Rate	5	5
Bradycardia	3	3
Unspecified Respiratory Problem	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
Low Blood Pressure/ Hypotension	2	2
Cerebral Edema	2	2
Pneumothorax	1	1
Failure of Implant	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
Cardiovascular Insufficiency	1	1