TPLC - Total Product Life Cycle

• Device: ventilator, emergency, manual (resuscitator)
• Product Code: BTM
• Regulation Number: 868.5915
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
FLEXICARE MEDICAL LIMITED
	SUBSTANTIALLY EQUIVALENT	1
FOREMOUNT ENTERPRISE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
XIAMEN COMPOWER MEDICAL TECH. CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2017	56	56
2018	53	53
2019	46	46
2020	26	26
2021	42	42
2022	9	9

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	17	17
Inflation Problem	16	16
Device Damaged Prior to Use	13	13
Defective Component	12	12
Component Missing	12	12
Defective Device	12	12
Device Operates Differently Than Expected	12	12
Appropriate Term/Code Not Available	12	12
Connection Problem	11	11
Device Issue	9	9
Device Operational Issue	9	9
Fitting Problem	8	8
Material Deformation	7	7
Detachment of Device or Device Component	6	6
Inadequacy of Device Shape and/or Size	6	6
Deflation Problem	6	6
Missing Value Reason	6	6
Loose or Intermittent Connection	5	5
Mechanical Problem	5	5
Device Dislodged or Dislocated	5	5
Gas Leak	5	5
No Flow	5	5
Disconnection	4	4
Collapse	4	4
Air Leak	4	4
Leak/Splash	4	4
Product Quality Problem	4	4
Therapeutic or Diagnostic Output Failure	4	4
Manufacturing, Packaging or Shipping Problem	3	3
Insufficient Information	3	3
Physical Resistance/Sticking	3	3
Unintended Deflation	3	3
Difficult to Remove	3	3
Material Puncture/Hole	3	3
Material Separation	3	3
Detachment Of Device Component	3	3
Difficult to Open or Close	3	3
Failure to Disconnect	3	3
Separation Failure	2	2
Failure to Deliver	2	2
Structural Problem	2	2
Packaging Problem	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Material Integrity Problem	2	2
Material Twisted/Bent	2	2
Crack	2	2
Disassembly	2	2
Device Alarm System	2	2
Use of Device Problem	2	2
Hole In Material	2	2
Nonstandard Device	2	2
No Device Output	1	1
Increase in Pressure	1	1
Material Too Rigid or Stiff	1	1
Improper or Incorrect Procedure or Method	1	1
Suction Problem	1	1
Invalid Sensing	1	1
Shipping Damage or Problem	1	1
Unexpected Therapeutic Results	1	1
Arcing at Paddles	1	1
Complete Blockage	1	1
Failure to Deliver Energy	1	1
Fire	1	1
Fluid Leak	1	1
Melted	1	1
Misconnection	1	1
Moisture Damage	1	1
Mechanical Jam	1	1
Improper Flow or Infusion	1	1
Incorrect Device Or Component Shipped	1	1
No Pressure	1	1
Optical Distortion	1	1
Pressure Problem	1	1
Expiration Date Error	1	1
Obstruction of Flow	1	1
Incomplete or Missing Packaging	1	1
Patient-Device Incompatibility	1	1
Device Markings/Labelling Problem	1	1
Device Misassembled During Manufacturing /Shipping	1	1
Activation, Positioning or SeparationProblem	1	1
Incomplete or Inadequate Connection	1	1
Suction Failure	1	1
Ventilation Problem in Device Environment	1	1
No Apparent Adverse Event	1	1
Patient Device Interaction Problem	1	1
Material Split, Cut or Torn	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	96	96
No Consequences Or Impact To Patient	34	34
Missing Value Reason	31	31
Insufficient Information	20	20
No Clinical Signs, Symptoms or Conditions	14	14
No Patient Involvement	14	14
Low Oxygen Saturation	13	13
Death	9	9
No Code Available	9	9
Cardiac Arrest	8	8
Hypoxia	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Not Applicable	3	3
No Information	2	2
Respiratory Arrest	2	2
Loss of consciousness	2	2
Low Blood Pressure/ Hypotension	2	2
Hypoventilation	1	1
Fracture, Arm	1	1
Anemia	1	1
Burn, Thermal	1	1
Pneumothorax	1	1
Respiratory Distress	1	1
Seizures	1	1
Cardiopulmonary Arrest	1	1
Dyspnea	1	1
Endocarditis	1	1
Unspecified Tissue Injury	1	1
Asystole	1	1
Cardiovascular Insufficiency	1	1
Foreign Body In Patient	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Sun Med, LLC	II	Jun-09-2018
2	Vyaire Medical	I	Aug-08-2018