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
1. K210288 Disposable Manual Resuscitator

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	21	21
Inflation Problem	15	15
Gas/Air Leak	15	15
Material Integrity Problem	12	12
Defective Device	10	10
Deflation Problem	10	10
Pressure Problem	8	8
Detachment of Device or Device Component	7	7
Failure to Deliver	6	6
Physical Resistance/Sticking	6	6
Crack	6	13
Material Fragmentation	6	6
Incomplete or Inadequate Connection	5	5
No Flow	5	5
Defective Component	5	5
Component Missing	5	5
Difficult to Open or Close	4	4
Infusion or Flow Problem	4	4
Therapeutic or Diagnostic Output Failure	4	4
Material Split, Cut or Torn	4	4
Unintended Deflation	4	4
Failure to Seal	4	4
Material Puncture/Hole	4	4
Disconnection	4	4
Fluid/Blood Leak	3	3
Mechanical Problem	3	3
Use of Device Problem	3	3
Loose or Intermittent Connection	3	3
Material Deformation	3	3
Output Problem	3	3
Obstruction of Flow	3	3
Structural Problem	2	2
Blocked Connection	2	2
Connection Problem	2	2
Incomplete or Missing Packaging	2	2
Tear, Rip or Hole in Device Packaging	2	2
Improper Flow or Infusion	2	2
Device Dislodged or Dislocated	2	2
Packaging Problem	2	2
Material Twisted/Bent	2	2
Insufficient Information	2	2
Device Handling Problem	2	2
No Device Output	2	2
Decrease in Pressure	2	2
Material Too Rigid or Stiff	2	2
Material Separation	2	2
Inadequacy of Device Shape and/or Size	2	2
Fitting Problem	2	2
Leak/Splash	2	2
Misassembled	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	86	89
Insufficient Information	35	39
Low Oxygen Saturation	25	25
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
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