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
Inflation Problem	13	13
Material Integrity Problem	10	10
Gas/Air Leak	10	10
Deflation Problem	9	9
Pressure Problem	8	8
Detachment of Device or Device Component	7	7
Physical Resistance/Sticking	6	6
Defective Device	6	6
Failure to Deliver	6	6
No Flow	5	5
Crack	5	12
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
Material Fragmentation	4	4
Component Missing	4	4
Infusion or Flow Problem	4	4
Fluid/Blood Leak	3	3
Mechanical Problem	3	3
Output Problem	3	3
Use of Device Problem	3	3
Obstruction of Flow	3	3
No Device Output	2	2
Loose or Intermittent Connection	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
Material Twisted/Bent	2	2
Improper Flow or Infusion	2	2
Material Too Rigid or Stiff	2	2
Defective Component	2	2
Incomplete or Missing Packaging	2	2
Disconnection	2	2
Insufficient Flow or Under Infusion	1	1
Decrease in Pressure	1	1
Misassembled	1	1
Partial Blockage	1	1
Incorrect Measurement	1	1
Product Quality Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	77	80
Insufficient Information	33	37
Low Oxygen Saturation	21	21
Cardiac Arrest	15	15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	14	14
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
Respiratory Arrest	2	2
Vomiting	2	2
Overinflation of Lung	2	2
Respiratory Failure	2	2
Low Blood Pressure/ Hypotension	2	2
Cerebral Edema	2	2
Pneumothorax	1	1
Hypoventilation	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