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
1. K243861 butterflyBVM
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	14	14
Gas/Air Leak	12	12
Material Integrity Problem	12	12
Break	10	10
Pressure Problem	8	8
Deflation Problem	8	8
Material Fragmentation	7	7
Disconnection	5	5
Unintended Deflation	5	5
Material Split, Cut or Torn	4	4
Loose or Intermittent Connection	4	4
Infusion or Flow Problem	4	4
Incomplete or Inadequate Connection	4	4
Crack	4	4
Defective Component	4	4
Defective Device	4	4
Failure to Deliver	4	4
Failure to Seal	3	3
No Flow	3	3
Difficult to Open or Close	3	3
Insufficient Device Problem Information	3	3
Component Missing	3	3
Mechanical Problem	3	3
No Device Output	2	2
Material Puncture/Hole	2	2
Fluid/Blood Leak	2	2
Use of Device Problem	2	2
Obstruction of Flow	2	2
Incomplete or Missing Packaging	2	2
Decrease in Pressure	2	2
Blocked Connection	2	2
Physical Resistance/Sticking	2	2
Output Problem	2	2
Device Reprocessing Problem	2	2
Material Deformation	2	2
Device Dislodged or Dislocated	2	2
Device Handling Problem	2	2
Detachment of Device or Device Component	2	2
Failure to Deliver Energy	1	1
Leak/Splash	1	1
Mechanical Jam	1	1
Premature Separation	1	1
Connection Problem	1	1
Suction Problem	1	1
Nonstandard Device	1	1
Fracture	1	1
Missing Information	1	1
Tear, Rip or Hole in Device Packaging	1	1
Incorrect Measurement	1	1
Partial Blockage	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	96	99
Insufficient Information	40	44
Low Oxygen Saturation	26	26
Cardiac Arrest	20	20
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	16	16
Decreased Level of Consciousness	16	16
No Known Impact Or Consequence To Patient	12	12
Hypoxia	9	9
No Consequences Or Impact To Patient	9	9
Respiratory Insufficiency	5	5
Decreased Respiratory Rate	5	5
Unspecified Respiratory Problem	4	4
Hypoventilation	3	3
Bradycardia	3	3
Loss of consciousness	3	3
Respiratory Failure	3	3
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
Death	1	1
Pneumothorax	1	1
Failure of Implant	1	1
No Code Available	1	1
Cardiovascular Dysfunction/Insufficiency	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