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
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
Break	18	18
Inflation Problem	13	13
Defective Device	10	10
Gas/Air Leak	10	10
Material Integrity Problem	9	9
Deflation Problem	9	9
Pressure Problem	8	8
Detachment of Device or Device Component	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
Failure to Seal	4	4
Difficult to Open or Close	4	4
Unintended Deflation	4	4
Defective Component	4	4
Therapeutic or Diagnostic Output Failure	4	4
Disconnection	3	3
Fluid/Blood Leak	3	3
No Flow	3	3
Mechanical Problem	3	3
Material Puncture/Hole	3	3
Material Separation	3	3
Infusion or Flow Problem	3	3
Use of Device Problem	3	3
Component Missing	3	3
Obstruction of Flow	3	3
Loose or Intermittent Connection	2	2
Connection Problem	2	2
Tear, Rip or Hole in Device Packaging	2	2
Inadequacy of Device Shape and/or Size	2	2
Device Handling Problem	2	2
Packaging Problem	2	2
Material Deformation	2	2
Material Twisted/Bent	2	2
Improper Flow or Infusion	2	2
Incomplete or Missing Packaging	2	2
Fitting Problem	2	2
Structural Problem	1	1
Blocked Connection	1	1
Material Too Rigid or Stiff	1	1
Material Fragmentation	1	1
Moisture Damage	1	1
Contamination	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Incorrect Measurement	1	1
Product Quality Problem	1	1
Insufficient Information	1	1
Collapse	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	63	63
Insufficient Information	27	27
Low Oxygen Saturation	19	19
Cardiac Arrest	17	17
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	14	14
No Known Impact Or Consequence To Patient	12	12
No Consequences Or Impact To Patient	9	9
Hypoxia	5	5
Decreased Respiratory Rate	5	5
Respiratory Arrest	4	4
Respiratory Insufficiency	4	4
Bradycardia	3	3
Unspecified Respiratory Problem	3	3
Loss of consciousness	3	3
Hypoventilation	2	2
Vomiting	2	2
Overinflation of Lung	2	2
Low Blood Pressure/ Hypotension	2	2
Respiratory Failure	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