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
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	19	19
Inflation Problem	13	13
Defective Device	10	10
Material Integrity Problem	10	10
Deflation Problem	10	10
Gas/Air Leak	10	10
Pressure Problem	8	8
Detachment of Device or Device Component	7	7
Physical Resistance/Sticking	6	6
Failure to Deliver	6	6
No Flow	5	5
Incomplete or Inadequate Connection	5	5
Crack	5	12
Failure to Seal	4	4
Material Split, Cut or Torn	4	4
Difficult to Open or Close	4	4
Material Puncture/Hole	4	4
Unintended Deflation	4	4
Defective Component	4	4
Therapeutic or Diagnostic Output Failure	4	4
Component Missing	4	4
Infusion or Flow Problem	4	4
Disconnection	3	3
Fluid/Blood Leak	3	3
Mechanical Problem	3	3
Material Deformation	3	3
Use of Device Problem	3	3
Obstruction of Flow	3	3
No Device Output	2	2
Loose or Intermittent Connection	2	2
Connection Problem	2	2
Tear, Rip or Hole in Device Packaging	2	2
Inadequacy of Device Shape and/or Size	2	2
Material Separation	2	2
Device Handling Problem	2	2
Packaging Problem	2	2
Blocked Connection	2	2
Structural Problem	2	2
Material Twisted/Bent	2	2
Improper Flow or Infusion	2	2
Material Too Rigid or Stiff	2	2
Incomplete or Missing Packaging	2	2
Fitting Problem	2	2
Insufficient Flow or Under Infusion	1	1
Decrease in Pressure	1	1
Misassembled	1	1
Material Fragmentation	1	1
Moisture Damage	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	69	72
Insufficient Information	32	36
Low Oxygen Saturation	22	22
Cardiac Arrest	15	15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	14	14
No Known Impact Or Consequence To Patient	12	12
No Consequences Or Impact To Patient	9	9
Hypoxia	5	5
Decreased Respiratory Rate	5	5
Respiratory Insufficiency	4	4
Bradycardia	3	3
Unspecified Respiratory Problem	3	3
Loss of consciousness	3	3
Hypoventilation	2	2
Respiratory Arrest	2	2
Vomiting	2	2
Overinflation of Lung	2	2
Low Blood Pressure/ Hypotension	2	2
Respiratory Failure	2	2
Cerebral Edema	2	2
Death	1	1
Pneumothorax	1	1
Failure of Implant	1	1
No Code Available	1	1
No Information	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