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
A PLUS MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
AMBU A/S
	SUBSTANTIALLY EQUIVALENT	2
ARCHEON
	SUBSTANTIALLY EQUIVALENT	1
FLEXICARE MEDICAL LIMITED
	SUBSTANTIALLY EQUIVALENT	1
FOREMOUNT ENTERPRISE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HERSILL, S.L.
	SUBSTANTIALLY EQUIVALENT	1
LAERDAL MEDICAL A/S
	SUBSTANTIALLY EQUIVALENT	1
MICROBVM SYSTEMS LTD
	SUBSTANTIALLY EQUIVALENT	1
NEOFORCE GROUP, INC.
	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
No Flow	75	75
Failure to Deliver	73	73
Break	47	47
Device Issue	31	31
Inflation Problem	31	31
Device Operates Differently Than Expected	28	28
Separation Failure	21	21
Device Operational Issue	21	21
Device Damaged Prior to Use	18	18
Deflation Problem	18	18
Defective Device	18	18
Disconnection	17	17
Detachment Of Device Component	17	17
Connection Problem	17	17
Difficult to Remove	16	16
Defective Component	16	16
Component Missing	15	15
Appropriate Term/Code Not Available	14	14
Material Integrity Problem	13	13
Fitting Problem	11	11
Detachment of Device or Device Component	11	11
Gas/Air Leak	11	11
Material Separation	10	10
Crack	10	10
Pressure Problem	9	9
Loose or Intermittent Connection	9	9
Missing Value Reason	8	8
Air Leak	8	8
Device Dislodged or Dislocated	8	8
Material Deformation	8	8
Material Split, Cut or Torn	7	7
Inadequacy of Device Shape and/or Size	7	7
Mechanical Problem	7	7
Use of Device Problem	7	7
Physical Resistance/Sticking	6	6
Device Handling Problem	6	6
Therapeutic or Diagnostic Output Failure	6	6
Insufficient Information	6	6
Activation, Positioning or Separation Problem	6	6
Manufacturing, Packaging or Shipping Problem	5	5
Incomplete or Inadequate Connection	5	5
Torn Material	5	5
Sticking	5	5
Product Quality Problem	5	5
Leak/Splash	5	5
Hole In Material	5	5
Packaging Problem	4	4
Collapse	4	4
Unintended Deflation	4	4
Kinked	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	250	250
No Clinical Signs, Symptoms or Conditions	54	54
Missing Value Reason	54	54
No Consequences Or Impact To Patient	50	50
Low Oxygen Saturation	29	29
Insufficient Information	27	27
Not Applicable	25	25
Cardiac Arrest	24	24
No Information	22	22
No Patient Involvement	21	21
Death	19	19
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	12	12
No Code Available	12	12
Hypoxia	12	12
Respiratory Distress	6	6
Decreased Respiratory Rate	5	5
Hypoventilation	4	4
Respiratory Insufficiency	4	4
Respiratory Arrest	4	4
Bradycardia	4	4
Loss of consciousness	3	3
Cerebral Edema	2	2
Respiratory Failure	2	2
Low Blood Pressure/ Hypotension	2	2
Unspecified Respiratory Problem	2	2
Dyspnea	2	2
Cardiopulmonary Arrest	2	2
Vomiting	2	2
Foreign Body In Patient	2	2
Confusion/ Disorientation	2	2
Overdose	2	2
Brain Injury	2	2
Pneumothorax	2	2
Loss Of Pulse	1	1
Pallor	1	1
Weakness	1	1
Overinflation of Lung	1	1
Asystole	1	1
Unspecified Tissue Injury	1	1
Endocarditis	1	1
Hyperventilation	1	1
Burn, Thermal	1	1
Therapeutic Response, Decreased	1	1
Cardiovascular Insufficiency	1	1
Obstruction/Occlusion	1	1
Anemia	1	1
Diminished Pulse Pressure	1	1
Seizures	1	1
Ventilator Dependent	1	1
Failure of Implant	1	1