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
Gas/Air Leak	10	10
Detachment of Device or Device Component	10	10
Deflation Problem	10	10
Pressure Problem	9	9
Device Damaged Prior to Use	9	9
Component Missing	7	7
Connection Problem	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
Mechanical Problem	4	4
Therapeutic or Diagnostic Output Failure	4	4
No Flow	4	4
Failure to Deliver	4	4
Difficult to Open or Close	4	4
Loose or Intermittent Connection	4	4
Unintended Deflation	4	4
Fitting Problem	3	3
Disconnection	3	3
Material Deformation	3	3
Use of Device Problem	3	3
Material Separation	3	3
Fluid/Blood Leak	3	3
Material Puncture/Hole	3	3
Device Handling Problem	2	2
Packaging Problem	2	2
Infusion or Flow Problem	2	2
Material Twisted/Bent	2	2
Inadequacy of Device Shape and/or Size	2	2
Tear, Rip or Hole in Device Packaging	2	2
Failure to Disconnect	2	2
Nonstandard Device	1	1
Improper or Incorrect Procedure or Method	1	1
Mechanical Jam	1	1
No Device Output	1	1
Failure to Seal	1	1
Moisture Damage	1	1
Contamination	1	1
Patient Device Interaction Problem	1	1
Optical Distortion	1	1
No Pressure	1	1
Device Misassembled During Manufacturing /Shipping	1	1
Structural Problem	1	1
Misconnection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	53	53
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
Respiratory Distress	1	1
Failure of Implant	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