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

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
No Flow	4	4
Loose or Intermittent Connection	4	4
Difficult to Open or Close	4	4
Failure to Deliver	4	4
Therapeutic or Diagnostic Output Failure	4	4
Unintended Deflation	4	4
Mechanical Problem	4	4
Material Puncture/Hole	3	3
Fluid/Blood Leak	3	3
Disconnection	3	3
Fitting Problem	3	3
Use of Device Problem	3	3
Material Deformation	3	3
Material Separation	3	3
Failure to Disconnect	2	2
Material Twisted/Bent	2	2
Tear, Rip or Hole in Device Packaging	2	2
Infusion or Flow Problem	2	2
Inadequacy of Device Shape and/or Size	2	2
Packaging Problem	2	2
Device Handling Problem	2	2
Failure to Seal	1	1
No Device Output	1	1
Mechanical Jam	1	1
Improper or Incorrect Procedure or Method	1	1
Failure to Deliver Energy	1	1
Premature Separation	1	1
Leak/Splash	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
Increase in Pressure	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	54	54
No Known Impact Or Consequence To Patient	36	36
Insufficient Information	26	26
Cardiac Arrest	18	18
Low Oxygen Saturation	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
Loss of consciousness	3	3
Hypoventilation	2	2
No Code Available	2	2
Vomiting	2	2
Bradycardia	2	2
Unspecified Respiratory Problem	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