TPLC - Total Product Life Cycle

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Device	ventilator, emergency, manual (resuscitator)
Product Code	BTM
Regulation Number	868.5915
Device Class	2

Premarket Reviews
Manufacturer	Decision
ARCHEON
	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	19	19
Break	18	18
Defective Device	13	13
Defective Component	11	11
Detachment of Device or Device Component	10	10
Gas/Air Leak	10	10
Deflation Problem	10	10
Pressure Problem	9	9
Device Damaged Prior to Use	9	9
Connection Problem	7	7
Component Missing	7	7
Material Integrity Problem	7	7
Material Split, Cut or Torn	6	6
Physical Resistance/Sticking	6	6
Incomplete or Inadequate Connection	5	5
Crack	5	5
Failure to Deliver	5	5
No Flow	4	4
Loose or Intermittent Connection	4	4
Difficult to Open or Close	4	4
Mechanical Problem	4	4
Unintended Deflation	4	4
Therapeutic or Diagnostic Output Failure	4	4
Fluid/Blood Leak	3	3
Material Separation	3	3
Material Deformation	3	3
Use of Device Problem	3	3
Disconnection	3	3
Material Puncture/Hole	3	3
Fitting Problem	3	3
Failure to Disconnect	2	2
Material Twisted/Bent	2	2
Infusion or Flow Problem	2	2
Tear, Rip or Hole in Device Packaging	2	2
Packaging Problem	2	2
Device Handling Problem	2	2
Inadequacy of Device Shape and/or Size	2	2
Failure to Seal	1	1
No Device Output	1	1
Failure to Deliver Energy	1	1
Mechanical Jam	1	1
Improper or Incorrect Procedure or Method	1	1
Leak/Splash	1	1
Premature Separation	1	1
Activation, Positioning or Separation Problem	1	1
Suction Problem	1	1
Unexpected Therapeutic Results	1	1
Nonstandard Device	1	1
Appropriate Term/Code Not Available	1	1
Device Dislodged or Dislocated	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	58	58
No Known Impact Or Consequence To Patient	36	36
Insufficient Information	27	27
Low Oxygen Saturation	19	19
Cardiac Arrest	18	18
No Consequences Or Impact To Patient	15	15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	12	12
No Patient Involvement	10	10
Decreased Respiratory Rate	5	5
Death	4	4
Respiratory Arrest	4	4
Hypoxia	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
Vomiting	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
Overinflation of Lung	1	1
Missing Value Reason	1	1
Asystole	1	1
Unspecified Tissue Injury	1	1
Endocarditis	1	1
Cardiovascular Insufficiency	1	1
Low Blood Pressure/ Hypotension	1	1