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
1. K212905 Sotair Device
XIAMEN COMPOWER MEDICAL TECH. CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	21	21
Inflation Problem	15	15
Gas/Air Leak	14	14
Material Integrity Problem	11	11
Defective Device	10	10
Deflation Problem	10	10
Pressure Problem	8	8
Detachment of Device or Device Component	7	7
Physical Resistance/Sticking	6	6
Crack	6	13
Failure to Deliver	6	6
No Flow	5	5
Incomplete or Inadequate Connection	5	5
Material Fragmentation	5	5
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
Output Problem	3	3
Loose or Intermittent Connection	3	3
Use of Device Problem	3	3
Obstruction of Flow	3	3
Material Deformation	3	3
No Device Output	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
Material Separation	2	2
Device Handling Problem	2	2
Packaging Problem	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
Insufficient Information	2	2
Incomplete or Missing Packaging	2	2
Fitting Problem	2	2
Leak/Splash	2	2
Insufficient Flow or Under Infusion	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	81	84
Insufficient Information	34	38
Low Oxygen Saturation	24	24
Cardiac Arrest	17	17
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	16	16
No Known Impact Or Consequence To Patient	12	12
No Consequences Or Impact To Patient	9	9
Hypoxia	6	6
Respiratory Insufficiency	5	5
Decreased Respiratory Rate	5	5
Hypoventilation	3	3
Bradycardia	3	3
Unspecified Respiratory Problem	3	3
Loss of consciousness	3	3
Respiratory Failure	3	3
Respiratory Arrest	2	2
Vomiting	2	2
Overinflation of Lung	2	2
Low Blood Pressure/ Hypotension	2	2
Cerebral Edema	2	2
Death	1	1
Pneumothorax	1	1
No Code Available	1	1
Failure of Implant	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