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
AMBU A/S
	SUBSTANTIALLY EQUIVALENT	1
ARCHEON
	SUBSTANTIALLY EQUIVALENT	1
FLEXICARE MEDICAL LIMITED
	SUBSTANTIALLY EQUIVALENT	1
FOREMOUNT ENTERPRISE CO., LTD.
	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	40	40
Device Issue	31	31
Inflation Problem	27	27
Device Operates Differently Than Expected	21	21
Separation Failure	21	21
Device Operational Issue	20	20
Deflation Problem	17	17
Defective Device	17	17
Difficult to Remove	16	16
Device Damaged Prior to Use	16	16
Appropriate Term/Code Not Available	14	14
Connection Problem	14	14
Defective Component	14	14
Component Missing	12	12
Material Integrity Problem	12	12
Gas/Air Leak	11	11
Detachment of Device or Device Component	10	10
Fitting Problem	9	9
Pressure Problem	9	9
Crack	9	9
Disconnection	8	8
Missing Value Reason	8	8
Material Deformation	7	7
Inadequacy of Device Shape and/or Size	7	7
Air Leak	7	7
Loose or Intermittent Connection	7	7
No Flow	7	7
Detachment Of Device Component	7	7
Mechanical Problem	7	7
Material Split, Cut or Torn	7	7
Therapeutic or Diagnostic Output Failure	6	6
Device Dislodged or Dislocated	6	6
Failure to Deliver	6	6
Physical Resistance/Sticking	6	6
Material Separation	6	6
Activation, Positioning or Separation Problem	6	6
Manufacturing, Packaging or Shipping Problem	5	5
Product Quality Problem	5	5
Incomplete or Inadequate Connection	5	5
Sticking	5	5
Failure to Disconnect	4	4
Unintended Deflation	4	4
Kinked	4	4
Collapse	4	4
Insufficient Information	4	4
Difficult to Open or Close	4	4
Packaging Problem	4	4
Leak/Splash	4	4
Material Puncture/Hole	3	3
Torn Material	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	148	148
No Clinical Signs, Symptoms or Conditions	54	54
Missing Value Reason	54	54
No Consequences Or Impact To Patient	41	41
Insufficient Information	27	27
Not Applicable	25	25
Low Oxygen Saturation	23	23
Cardiac Arrest	20	20
No Patient Involvement	19	19
No Information	14	14
Death	13	13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	12	12
No Code Available	10	10
Hypoxia	9	9
Decreased Respiratory Rate	5	5
Respiratory Insufficiency	4	4
Respiratory Arrest	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
Bradycardia	2	2
Dyspnea	2	2
Vomiting	2	2
Hypoventilation	2	2
Cardiopulmonary Arrest	1	1
Foreign Body In Patient	1	1
Weakness	1	1
Asystole	1	1
Unspecified Tissue Injury	1	1
Endocarditis	1	1
Burn, Thermal	1	1
Cardiovascular Insufficiency	1	1
Anemia	1	1
Diminished Pulse Pressure	1	1
Brain Injury	1	1
Seizures	1	1
Respiratory Distress	1	1
Failure of Implant	1	1
Pneumothorax	1	1
Fracture, Arm	1	1