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
Inflation Problem	21	21
Break	20	20
Defective Device	13	27
Deflation Problem	11	11
Defective Component	11	11
Gas/Air Leak	10	10
Material Integrity Problem	10	10
Detachment of Device or Device Component	10	10
Pressure Problem	9	9
Device Damaged Prior to Use	9	9
Component Missing	8	8
Connection Problem	7	7
Failure to Deliver	6	6
No Flow	6	6
Physical Resistance/Sticking	6	6
Crack	6	27
Incomplete or Inadequate Connection	5	5
Material Puncture/Hole	5	5
Infusion or Flow Problem	4	4
Material Deformation	4	4
Therapeutic or Diagnostic Output Failure	4	4
Unintended Deflation	4	4
Difficult to Open or Close	4	4
Loose or Intermittent Connection	4	4
Mechanical Problem	4	4
Material Split, Cut or Torn	4	4
Failure to Seal	4	4
Incomplete or Missing Packaging	3	3
Fluid/Blood Leak	3	3
Fitting Problem	3	3
Use of Device Problem	3	3
Obstruction of Flow	3	3
Disconnection	3	3
Device Dislodged or Dislocated	2	2
Tear, Rip or Hole in Device Packaging	2	2
Inadequacy of Device Shape and/or Size	2	2
Failure to Disconnect	2	2
Material Separation	2	2
Device Handling Problem	2	2
Packaging Problem	2	2
No Device Output	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
Decrease in Pressure	1	1
Insufficient Flow or Under Infusion	1	1
No Pressure	1	15
Device Misassembled During Manufacturing /Shipping	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	70	73
No Known Impact Or Consequence To Patient	36	50
Insufficient Information	34	38
Low Oxygen Saturation	24	24
Cardiac Arrest	16	16
No Consequences Or Impact To Patient	15	15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	14	14
No Patient Involvement	10	10
Hypoxia	5	5
Decreased Respiratory Rate	5	5
Death	4	4
Respiratory Insufficiency	4	4
Bradycardia	3	3
Unspecified Respiratory Problem	3	3
Loss of consciousness	3	3
Hypoventilation	2	2
No Code Available	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
Pneumothorax	1	1
Failure of Implant	1	1
Respiratory Distress	1	1
No Information	1	1
Diminished Pulse Pressure	1	1
Anemia	1	1
Foreign Body In Patient	1	1
Dyspnea	1	1
Missing Value Reason	1	1
Asystole	1	1
Unspecified Tissue Injury	1	1
Endocarditis	1	1
Cardiovascular Insufficiency	1	1